Identity
- Trade Name
- Soft Face Mallet FDA UDI
- Generic Name
- Surgical mallet head FDA UDI
- Device Name
- Soft Face Mallet 750 gram FDA UDI
- Model / Reference
- 750 gram FDA UDI
- Description
- Soft Face Mallet 750 gram FDA UDI
Identifiers
- Catalog Number
- BIO-1-1090 FDA UDI
- Primary DI / UDI-DI
- B046BIO110900 FDA UDI
- FDA Product Code
- GFJ FDA UDI
- GMDN Term
- Surgical mallet head FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
No
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 malletSurgical mallet head
Soft Face Mallet by Signal Medical Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical mallet head.
- Omnia Medical PsiF — Omnia Medical · Class I
- Nylon Head For Deluxe Mallet — SONTEC INSTRUMENTS, INC. · Class I
- NYLON HEAD — SONTEC INSTRUMENTS, INC. · Class I
- COTTLE BONE MALLET — SONTEC INSTRUMENTS, INC. · Class I
- Sklar® — Sklar Corporation · Class I
- Pomee — POMEE CORPORATION · Class I
- Alliant Biotech — Medisurge · Class I
- TESSYS® — JOIMAX, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Signal Medical Corp.
Sources (1)
- FDA UDI beddb174-415e-4d75-afb7-c27b2f07819f 35 fields · synced May 29, 2026