Identity
- Trade Name
- KEYPORT FDA UDI
- Generic Name
- Laparoscopic multi-instrument access port, reusable FDA UDI
- Device Name
- SILICONE SEALING INSERT with three valve accesses, PACK=3 PCS, with connection for CO2 insufflation / smoke aspiration, reusable FDA UDI
- Model / Reference
- 8850243 FDA UDI
- Description
- SILICONE SEALING INSERT with three valve accesses, PACK=3 PCS, with connection for CO2 insufflation / smoke aspiration, reusable FDA UDI
Identifiers
- Catalog Number
- 8850243 FDA UDI
- Primary DI / UDI-DI
- 04055207021071 FDA UDI
- FDA Product Code
- OTJ FDA UDI
- GMDN Term
- Laparoscopic multi-instrument access port, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
Keyport by Richard Wolf GmbH — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
Sources (1)
- FDA UDI e88d787b-813d-4837-801e-22530acf765b 36 fields · synced May 30, 2026