FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgical Direct
DI: B382SD3115H0
·
Model: SD3115H
·
Surgical Direct, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Surgical Direct
- Primary DI
- B382SD3115H0
- Version / Model
- SD3115H
- Catalog Number
- SD3115H
- Company Name
- Surgical Direct, Inc.
- Labeler DUNS
- 124367223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-28
- Public Version
- 1
- Public Version Date
- 2020-05-06
- Public Version Status
- New
- Public Device Record Key
- 56d40d22-7a83-4837-b788-d8d59b56c50b
Device Description
90° Headlight consisting of:1 - Premium double adjustable headgear 1 - Black headlight module, 90° 10-100mm variable spot 2 - Joysticks, detachable; 1 - Set of cushioned detachable Black sweatbands 1 - Bifurcated cable, 9ft with Wolf lens proximal
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FST | Light, Surgical, Fiberoptic | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46808 | Head-worn fibreoptic light | A fibreoptic device mounted on a headband or helmet frame to convey cold light from a connected light source (not included) directly onto the field of vision during a medical or surgical procedure. It typically consists of a magnifying lens, a reflector, and a fibreoptic cable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B382SD3115H0 | HIBCC |
Customer Contacts
- Phone
- +1 (800) 519-3293
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061690 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10100 | Centimeter |