Identity
- Trade Name
- IMEDICOM SAW BLADE FDA UDI
- Generic Name
- Surgical saw blade, sagittal, single-use FDA UDI
- Model / Reference
- KDS-970B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809317173443 FDA UDI
- FDA Product Code
- GFA FDA UDI
- GMDN Term
- Surgical saw blade, sagittal, 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical saw blade, sagittal, single-useSurgical saw blade, reciprocating, single-use
A comprehensive 2-3 paragraph SEO description written in clear, natural language. The IMEDICOM SAW BLADE is a versatile surgical saw blade designed for use in orthopaedic and oral surgery.
Similar devices
Also classified as Surgical saw blade, reciprocating, single-use.
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- KOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KG · Class I
- Stablecut® — Zimmer Orthopaedic Surgical Products · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- OXFORD PARTIAL KNEE — Biomet Orthopedics, Inc. · Class I
- KOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KG · 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
- Imedicom Co., Ltd.
Sources (1)
- FDA UDI d7df4424-5cef-4291-8fe6-e8bc9496076f 32 fields · synced Jul 26, 2026