Ambler Surgical
- Primary DI
- 00190660106331
- Brand
- Ambler Surgical
- Company
- AMBLER SURGICAL CORP.
- Model
- Tuning fork
- Catalog number
- 43-854
- Device description
- Tuning fork, C1024, without weights, alluminum alloy
- Published
- 2021-01-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- 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 |
|---|
| 00190660106331 | Primary | GS1 | 0 | |
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 |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +1(888)407-0006 | sales@amblersurgical.com |
Regulatory Flags
- DUNS number
- 015272206
- 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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00190660029340 | Ambler Surgical | Thornton triple vertical and 15 degree cutting edg | 21-328E | 2021-01-18 |
| 00190660000509 | Ambler Surgical | Tendon approximator | 43-160 | 2021-01-07 |
| 00190660002121 | Ambler Surgical | Air injection cannula | 1022E | 2021-01-07 |
| 00190660002138 | Ambler Surgical | Air injection cannula | 1328E | 2021-01-07 |
| 00190660002145 | Ambler Surgical | Air injection cannula | 1023E | 2021-01-07 |
| 00190660002152 | Ambler Surgical | Air injection cannula | 1031E | 2021-01-07 |
| 00190660002169 | Ambler Surgical | Air injection cannula | 1329E | 2021-01-07 |
| 00190660002176 | Ambler Surgical | Air injection cannula | 1026E | 2021-01-07 |
| 00190660002183 | Ambler Surgical | Air injection cannula | 1024E | 2021-01-07 |
| 00190660002190 | Ambler Surgical | Air injection cannula | 1028E | 2021-01-07 |
| 00190660002206 | Ambler Surgical | Air injection cannula | 1029E | 2021-01-07 |
| 00190660002213 | Ambler Surgical | Air injection cannula | 1027E | 2021-01-07 |
| 00190660002237 | Ambler Surgical | Air injection cannula | 1327E | 2021-01-07 |
| 00190660002244 | Ambler Surgical | Air injection cannula | 1030E | 2021-01-07 |
| 00190660002268 | Ambler Surgical | Air injection cannula | 1330E | 2021-01-07 |
| 00190660002329 | Ambler Surgical | Alio LASIK irrigation cannula | 5193E | 2021-01-07 |
| 00190660002343 | Ambler Surgical | Anis cortex aspirating cannula | 1429E | 2021-01-07 |
| 00190660002350 | Ambler Surgical | Anis cortex aspirating cannula | 1097E | 2021-01-07 |
| 00190660002824 | Ambler Surgical | Binkhorst irrigating cannula | 1332E | 2021-01-07 |
| 00190660002831 | Ambler Surgical | Binkhorst irrigating cannula | 1333E | 2021-01-07 |
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