FDA UDI
In Commercial Distribution
🇺🇸 United States
BR Surgical, LLC
DI: 00857556008239
·
Model: BR946-4030-175
·
BR Surgical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BR Surgical, LLC
- Primary DI
- 00857556008239
- Version / Model
- BR946-4030-175
- Catalog Number
- BR946-4030-175
- Company Name
- BR Surgical, LLC
- Labeler DUNS
- 134781207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-15
- Public Version
- 2
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 5ac933fd-a16a-4117-ac24-41aaac743602
Device Description
Sinus Scope, autoclavable, Ø 4mm, 30º, 175mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide, Hydrogen Peroxide, Moist Heat or Steam Sterilization, High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOB | Nasopharyngoscope (flexible or rigid) | Ear, Nose, Throat | 874.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37180 | Rigid optical sinoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857556008239 | GS1 |
Customer Contacts
- Phone
- +1(904)642-1366
- [email protected]