Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Rigid optical arthroscope, reusable FDA UDI
- Device Name
- 4mm 30 Degree Cystoscope, Autoclavable, High Performance German Optics, ACMI Connector FDA UDI
- Model / Reference
- SD804-307 FDA UDI
- Description
- 4mm 30 Degree Cystoscope, Autoclavable, High Performance German Optics, ACMI Connector FDA UDI
Identifiers
- Catalog Number
- SD804-307 FDA UDI
- Primary DI / UDI-DI
- B382SD8043070 FDA UDI
- 510(k) Number
- K031972 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Rigid optical arthroscope, reusable 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
No
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 arthroscope, reusable
Surgical Direct by Surgical Direct, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical arthroscope, reusable.
- Arthrex® — Arthrex, Inc. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Precision Ideal Eyes — Stryker Corp. · Class II
- Arthrex® — Arthrex, Inc. · Class I
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 |
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Manufacturer
- Manufacturer
- Surgical Direct, Inc.
Sources (1)
- FDA UDI 06fccc23-300a-4c2f-be22-7412c2f3a383 36 fields · synced May 30, 2026