BR Surgical, LLC
- Primary DI
- 00840183501976
- Brand
- BR Surgical, LLC
- Company
- BR Surgical, LLC
- Model
- BR44-06001
- Catalog number
- BR44-06001
- Device description
- BRS Tuning Fork, aluminum alloy, C-128
- Published
- 2023-02-24
- 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 Code Classifications
| Code | Device | Specialty | Class |
|---|
| GWX | Fork, Tuning | Neurology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840183501976 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840183501976 | 00840183501976 | 840183501976 | 0840183501976 |
GMDN Terms
| Term | Definition |
|---|
| Tuning fork | A hand-held, mechanical test instrument designed as an acoustic resonator used to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense. It is usually made of stainless steel in the form of a two-pronged fork with the prongs (tines) formed from a U-shaped bar with a handle attached at the base of the "U". It resonates at a specific constant pitch when set vibrating by striking it against a surface or with an object. The pitch that a particular tuning fork generates depends on the length of the two prongs. 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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