Identity
- Trade Name
- SHARD FDA UDI
- Generic Name
- Manual scalpel blade, single-use FDA UDI
- Device Name
- SHARD Disposable Surgical Chisel Blades , Sterile. Size 65. FDA UDI
- Model / Reference
- A600-M65 FDA UDI
- Description
- SHARD Disposable Surgical Chisel Blades , Sterile. Size 65. FDA UDI
Identifiers
- Catalog Number
- A600-M65 FDA UDI
- Primary DI / UDI-DI
- 00814639025019 FDA UDI
- FDA Product Code
- GFA FDA UDI
- GMDN Term
- Manual scalpel blade, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Manual scalpel blade, single-use
Shard by Applied Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual scalpel blade, single-use.
- Paramount — Paramount Surgimed Limited · Class IIa
- Bard-Parker ® Carbon Rib-Back Blades — Aspen Surgical Products, Inc. · Class I
- Swann-Morton — Swann-Morton Ltd · Class IIa
- Sterile Stainless Blades — Southmedic Incorporated · Class I
- Paramount — Paramount Surgimed Limited · Class IIa
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SURGISTAR — Surgistar Inc. · Class I
- Olympus — Olympus Winter & Ibe GmbH · Class II
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
- Applied Dental, Inc.
Sources (1)
- FDA UDI be7a39f1-6bc6-4979-b2f2-ae5e3eb60c21 36 fields · synced Jun 6, 2026