Gamma3® (UDI 07613327298192)
Manufactured by Stryker GmbH
Device Regulatory Overview
The Gamma3® (Model/Catalog Number: 1320-8201) is a medical device manufactured by Stryker GmbH. This product is indexed under FDA Product Code / Category Classification P091280 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
- 1320-8201
- Product Code / EMDN
- P091280
- Device Name
- GAMMA3 INSTRUMENTS - HANDLES AND ADAPTORS - CLASS IIA - NON STERILE
- Database Sync Date
- 2026-08-09 16:49:06
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 Gamma3®?
The registered manufacturer of record for Gamma3® is Stryker GmbH.
What is the Primary UDI-DI identifier for Gamma3®?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07613327298192.
What classification code is assigned to this device?
This device is registered under product classification code P091280.
Similar Classification Devices (P091280)
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