MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. (UDI Z-0751-2014)
Manufactured by The Anspach Effort, Inc.
Device Regulatory Overview
The MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. (Model/Catalog Number: Unspecified) is a medical device manufactured by The Anspach Effort, Inc.. This product is indexed under FDA Product Code / Category Classification All lots within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- N/A
- Product Code / EMDN
- All lots
- Device Name
- MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
- Database Sync Date
- 2026-08-09 10:06:40
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.?
The registered manufacturer of record for MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. is The Anspach Effort, Inc..
What is the Primary UDI-DI identifier for MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0751-2014.
What classification code is assigned to this device?
This device is registered under product classification code All lots.
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Other Devices by The Anspach Effort, Inc.
- → 6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
- → 7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
- → Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
- → 7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
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