gudid
Primary ID: 5758E
Ambler Surgical (UDI 5758E)
Manufactured by AMBLER SURGICAL CORP.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Ambler Surgical - Primary ID 5758E
Device Regulatory Overview
The Ambler Surgical (Model/Catalog Number: 5758E) is a medical device manufactured by AMBLER SURGICAL CORP.. This product is indexed under FDA Product Code / Category Classification HKY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 5758E
- Product Code / EMDN
- HKY
- Device Name
- Schiotz tonometer weight - 5.5 gram, must send entire unit in for service when ordering this replacement part, service charge included in price listed
- Database Sync Date
- 2026-08-09 09:01:45
Full Regulatory Attributes
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{
"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 Ambler Surgical?
The registered manufacturer of record for Ambler Surgical is AMBLER SURGICAL CORP..
What is the Primary UDI-DI identifier for Ambler Surgical?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5758E.
What classification code is assigned to this device?
This device is registered under product classification code HKY.
Similar Classification Devices (HKY)
Other Devices by AMBLER SURGICAL CORP.
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