FDA UDI
In Commercial Distribution
🇺🇸 United States
BR Surgical, LLC
DI: 00840183520694
·
Model: BR46-90002
·
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
- 00840183520694
- Version / Model
- BR46-90002
- Catalog Number
- BR46-90002
- Company Name
- BR Surgical, LLC
- Labeler DUNS
- 134781207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-19
- Public Version
- 1
- Public Version Date
- 2024-07-29
- Public Version Status
- New
- Public Device Record Key
- ace95244-785b-41d5-940d-5286b7e16f30
Device Description
Minor FESS Set, includes: Weil Blakesley fcp 3.5mm str, Weil Blakesley fcp 3.5mm 45° up, Weil Blakesley Thru-Cut 3.5mm str, Weil Blakesley Thru-Cut 3.0mm 45° up, Turbinate Reduction fcp, Freer elevator s/b, Frontal Sinus Seeker, Maxillary Sinus Seeker, Filter, Paper Sterilization Indicators, and Sterilization tray w/mat 12 1/4" x 7 1/2" x 2 1/2"
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Serial Number
- No
- 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, Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OGR | Ear, Nose, And Throat Surgical Tray | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44067 | ENT surgical procedure kit, non-medicated, reusable | A collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840183520694 | GS1 |
Customer Contacts
- Phone
- 1-904-642-1366
- [email protected]