Identity
- Trade Name
- ELAN 4 FDA UDI
- Generic Name
- Surgical saw blade, reciprocating, single-use FDA UDI
- Device Name
- DISP.RECIPROCAT.SAW BLADE LONG 27/0.6 FDA UDI
- Model / Reference
- GP563SU FDA UDI
- Description
- DISP.RECIPROCAT.SAW BLADE LONG 27/0.6 FDA UDI
Identifiers
- Catalog Number
- GP563SU FDA UDI
- Primary DI / UDI-DI
- 04046955157631 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Surgical saw blade, reciprocating, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical saw blade, reciprocating, single-use
Elan 4 by Aesculap, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical saw blade, reciprocating, single-use.
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- 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 II | Pending data |
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Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (1)
- FDA UDI 721c940f-d25d-4289-80dc-4edc6ce235e0 35 fields · synced Jun 1, 2026