Identity
- Trade Name
- ZOLL-DENTAL FDA UDI
- Generic Name
- Surgical mallet head FDA UDI
- Device Name
- Replacement Resin Faces For Modern-Mallet (2 per package) FDA UDI
- Model / Reference
- Z-6309-R FDA UDI
- Description
- Replacement Resin Faces For Modern-Mallet (2 per package) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840105219743 FDA UDI
- FDA Product Code
- KOA FDA UDI
- GMDN Term
- Surgical mallet head FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
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 head
Zoll-Dental by Zoll-Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical mallet head.
- Soft Face Mallet — Signal Medical Corp. · Class I
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- 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
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 |
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Manufacturer
- Manufacturer
- Zoll-Dental
Sources (1)
- FDA UDI 0219f2a5-3933-4b5e-9782-521cfd8e929f 34 fields · synced Jun 8, 2026