Identity
- Trade Name
- Hammer FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Model / Reference
- 110302400 FDA UDI
Identifiers
- Catalog Number
- 110302400 FDA UDI
- Primary DI / UDI-DI
- 06902139111654 FDA UDI
- 510(k) Number
- K131609 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Surgical mallet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
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
Hammer by Double Medical Technology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131609 also covers:
- 4.0mm Locking Screw — Double Medical Technology Inc.
- 4.0mm Locking Screw — Double Medical Technology Inc.
- 4.0mm Locking Screw — Double Medical Technology Inc.
- 4.5mm Locking Screw for Tibial Nail — Double Medical Technology Inc.
- 4.5mm Locking Screw for Tibial Nail — Double Medical Technology Inc.
- 4.5mm Locking Screw for Tibial Nail — Double Medical Technology Inc.
- 4.9mm Locking Screw for DFN II/UFN II/UTN II — Double Medical Technology Inc.
- 4.9mm Locking Screw for DFN II/UFN II/UTN II — Double Medical Technology Inc.
- 4.9mm Locking Screw for DFN II/UFN II/UTN II — Double Medical Technology Inc.
- 4.9mm Locking Screw for DFN II/UFN II/UTN II — Double Medical Technology Inc.
- 5.0mm Dual Core Locking Screw — Double Medical Technology Inc.
- 5.0mm Dual Core Locking Screw — Double Medical Technology Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Double Medical Technology Inc.
Sources (1)
- FDA UDI e471567a-297f-4544-8f90-9ab6d1bc08d6 35 fields · synced May 30, 2026