Identity
- Trade Name
- Brasseler USA FDA UDI
- Generic Name
- Surgical saw blade, reciprocating, single-use FDA UDI
- Device Name
- KM5100-137-123 27.0 X 6.4MM FDA UDI
- Model / Reference
- 5008263M0 FDA UDI
- Description
- KM5100-137-123 27.0 X 6.4MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887919494706 FDA UDI
- FDA Product Code
- GFA FDA UDI
- GMDN Term
- Surgical saw blade, reciprocating, 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical saw blade, reciprocating, single-use
Brasseler USA by Peter Brasseler Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical saw blade, reciprocating, single-use.
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- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- KOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KG · Class I
- Stablecut® — Zimmer Orthopaedic Surgical Products · Class I
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · 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
- Peter Brasseler Holdings, LLC
Sources (1)
- FDA UDI 42b263f6-0bbe-4cd0-bffa-ec5dc5b00f5d 33 fields · synced Jun 1, 2026