Identity
- Trade Name
- ENDO-SPIKE FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- NEEDLES FOR STITCHING FORCEPS for ENDO-SPIKE 891403000, PACK = 5 PCS, sterile, for single use FDA UDI
- Model / Reference
- 491403000 FDA UDI
- Description
- NEEDLES FOR STITCHING FORCEPS for ENDO-SPIKE 891403000, PACK = 5 PCS, sterile, for single use FDA UDI
Identifiers
- Catalog Number
- 491403000 FDA UDI
- Primary DI / UDI-DI
- 04055207049150 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- General-purpose endoscopic needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Endo-Spike by Richard Wolf GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Richard Wolf GmbH
Sources (1)
- FDA UDI d2ce969b-d376-4902-aed3-b14edaa199ae 37 fields · synced May 30, 2026