BR Surgical, LLC
- Primary DI
- 00840183508463
- Brand
- BR Surgical, LLC
- Company
- BR Surgical, LLC
- Model
- BR42-61400
- Catalog number
- BR42-61400
- Device description
- BOWMAN Lacrimal Probe, cylindrical, malleable, size 00/0
- Published
- 2023-03-07
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| HNL | Probe, Lachrymal |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HNL | Probe, Lachrymal | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840183508463 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840183508463 | 00840183508463 | 840183508463 | 0840183508463 |
GMDN Terms
| Term | Definition |
|---|
| Ophthalmic surgical probe, reusable | A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Ethylene Oxide;Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 134781207
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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