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Latch-Lock Hex Driver with GemLock Retention 2.5mm (D) X 30mm (L)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref GHX2.5DL
Identity
- Trade Name
- GemLock® Drivers EUDAMEDLatch-Lock Hex Driver with GemLock Retention 2.5mm (D) X 30mm (L) FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Non sterile powered invasive instrument EUDAMED
- Model / Reference
- GHX2.5DL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844868047117 EUDAMEDFDA UDI
- Basic UDI-DI
- 844868AMJG EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.5 Millimeter FDA UDILength — 30 Millimeter FDA UDI
Category: Surgical screwdriver, reusable
Latch-Lock Hex Driver with GemLock Retention 2.5mm (D) X 30mm (L) by Biomet 3i, Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Surgical screwdriver, reusable.
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- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biomet 3i, Llc
Sources (2)
- FDA UDI 144b94e8-f97e-4cbe-a241-3620853ab624 34 fields · synced Aug 1, 2026
- EUDAMED f38bddc3-f388-45b7-a4a1-f1bfe5cb674e 61 fields · synced Aug 1, 2026