Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Rigid video laparoscope FDA UDI
- Device Name
- 5.0mm 30 Degree Laparoscope 170.0mm Autoclavable, Made in Germany, With Blue Eye Piece FDA UDI
- Model / Reference
- SD805-800 FDA UDI
- Description
- 5.0mm 30 Degree Laparoscope 170.0mm Autoclavable, Made in Germany, With Blue Eye Piece FDA UDI
Identifiers
- Catalog Number
- SD805-800 FDA UDI
- Primary DI / UDI-DI
- B382SD8058000 FDA UDI
- 510(k) Number
- K031972 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Rigid video laparoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid video laparoscope
Surgical Direct by Surgical Direct, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid video laparoscope.
- FUJIFILM — FUJIFILM Corporation · Class II
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Xenoscope 0° — Xenocor, Inc. · Class II
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
- SurroundScope Endoscope — 270surgical , Ltd. · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- Pixa — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
Cleared under the same submission
K031972 also covers:
- Surgical Direct — SURGICAL DIRECT, INC.
- Surgical Direct — SURGICAL DIRECT, INC.
- Surgical Direct — SURGICAL DIRECT, INC.
- Surgical Direct — SURGICAL DIRECT, INC.
- Surgical Direct — SURGICAL DIRECT, INC.
- Surgical Direct — SURGICAL DIRECT, INC.
- Surgical Direct — SURGICAL DIRECT, INC.
- Surgical Direct — SURGICAL DIRECT, INC.
- Surgical Direct — SURGICAL DIRECT, INC.
- Surgical Direct — SURGICAL DIRECT, INC.
- Surgical Direct — SURGICAL DIRECT, INC.
- Surgical Direct — SURGICAL DIRECT, INC.
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
- Surgical Direct, Inc.
Sources (1)
- FDA UDI 2665efb2-d50a-492d-991f-bccfb1bba44d 36 fields · synced May 30, 2026