Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Head-worn fibreoptic light FDA UDI
- Device Name
- Surgical Headlight..1 - Headgear light weight single back adjustment..1 - Black headlight module, 90° 10-100mm variable spot..2 - Joysticks, detachable..1 - Set of cushioned detachable Blue foam sweatbands..1 - Mono-cable, 9ft with Wolf lens proximal FDA UDI
- Model / Reference
- SD3120H FDA UDI
- Description
- Surgical Headlight..1 - Headgear light weight single back adjustment..1 - Black headlight module, 90° 10-100mm variable spot..2 - Joysticks, detachable..1 - Set of cushioned detachable Blue foam sweatbands..1 - Mono-cable, 9ft with Wolf lens proximal FDA UDI
Identifiers
- Catalog Number
- SD3120H FDA UDI
- Primary DI / UDI-DI
- B382SD3120H0 FDA UDI
- 510(k) Number
- K061690 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- Head-worn fibreoptic light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
Dimensions & Sizes
- Size
- Length — 10100 Centimeter FDA UDI
Category: Head-worn fibreoptic light
Surgical Direct by Surgical Direct, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Head-worn fibreoptic light.
- Sunoptic Technologies — Sunoptic Technologies · Class II
- 90 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- 105 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- 90 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- Surgical Headlight — GULF FIBEROPTICS, INC. · Class II
Cleared under the same submission
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 483351e3-9f92-495d-9c8b-bd24f4932ae3 37 fields · synced May 30, 2026