Identity
- Trade Name
- Adler Instrument Company FDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- Laparoscope, 5mm, 45 degree FDA UDI
- Model / Reference
- 62-4005 FDA UDI
- Description
- Laparoscope, 5mm, 45 degree FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810123204809 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical laparoscope
Adler Instrument Company by Adler, Inc. — 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 |
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Manufacturer
- Manufacturer
- Adler, Inc.
Sources (1)
- FDA UDI 9a80e704-6d80-4035-b4fb-790a56553f15 34 fields · synced Jun 8, 2026