Identity
- Trade Name
- LAP 5.5/0/300 HD3 FDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- LAP 5.5/0/300 HD3 AK HM FDA UDI
- Model / Reference
- 8300053462 FDA UDI
- Description
- LAP 5.5/0/300 HD3 AK HM FDA UDI
Identifiers
- Catalog Number
- 8300053462 FDA UDI
- Primary DI / UDI-DI
- 04035873066446 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid optical laparoscope 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical laparoscope
Lap 5.5/0/300 Hd3 by Henke-Sass, Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical laparoscope.
- Laparoscope — SOPRO-COMEG GmbH · Class II
- ELMED — ELMED INCORPORATED · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- MEDIVISION — MEDIVISION, INC. · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- CONMED — Conmed Corporation · Class II
- ELMED — ELMED INCORPORATED · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
Sources (1)
- FDA UDI 8dcb0994-fc9e-41ff-a7b4-e679c71da2d5 34 fields · synced May 30, 2026