Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Surgical instrument seal/seal maintenance set FDA UDI
- Device Name
- SEAL Resectoscope, PACK=6 PCS, reusable FDA UDI
- Model / Reference
- 8655996 FDA UDI
- Description
- SEAL Resectoscope, PACK=6 PCS, reusable FDA UDI
Identifiers
- Catalog Number
- 8655.996 FDA UDI
- Primary DI / UDI-DI
- 04055207019016 FDA UDI
- FDA Product Code
- FDC FDA UDI
- GMDN Term
- Surgical instrument seal/seal maintenance set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument seal/seal maintenance set
E-Line by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Richard Wolf GmbH
Sources (1)
- FDA UDI d0aad9a5-0615-49f1-960b-f2519c73f247 35 fields · synced May 31, 2026