Identity
- Trade Name
- Heath Mallet 7 1/4", 2lb [906g], head s/s Ø 45mm, alum hdl EUDAMEDgSource FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Device Name
- Mallet EUDAMEDHeath Mallet 7 1/4", 2lb [906g], head s/s Ø 45mm, alum hdl FDA UDI
- Model / Reference
- gS 59.7629 EUDAMEDFDA UDI
- Description
- Heath Mallet 7 1/4", 2lb [906g], head s/s Ø 45mm, alum hdl FDA UDI
Identifiers
- Catalog Number
- gS 59.7629 FDA UDI
- Primary DI / UDI-DI
- 00840314231536 EUDAMEDFDA UDI
- Basic UDI-DI
- 08403142IMPACTINGZV EUDAMED
- Direct Marketing DI
- 00840314231536 EUDAMED
- FDA Product Code
- GFJ FDA UDI
- EMDN Code
- L0903 ORTHOPAEDIC SURGERY HAMMERS, REUSABLE EUDAMED
- GMDN Term
- Surgical mallet FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical mallet
gSource by Gsource, Llc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Gsource, Llc.
Sources (2)
- FDA UDI 3fddb025-f251-4f19-8486-dfbdea060e17 34 fields · synced Jun 19, 2026
- EUDAMED 234a5908-f181-46c2-a655-bc985033e4f7 61 fields · synced Jun 19, 2026