Ambler Surgical
- Primary DI
- 00190660218072
- Brand
- Ambler Surgical
- Company
- AMBLER SURGICAL CORP.
- Model
- Distractor multi-level
- Catalog number
- 43-116
- Device description
- Distractor multi-level, left, 120.0mm
- Published
- 2021-01-07
- 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 Codes
| Code | Name |
|---|
| GZT | RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00190660218072 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00190660218072 | 00190660218072 | 190660218072 | 0190660218072 |
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic surgical distractor, external | A hand-operated surgical instrument designed to noninvasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure (e.g., hip arthroscopy). It is a mechanical tool with a manual trigger, for distraction and release, intended to be stabilized against a fixation point adjacent to the target joint (e.g., between the knee and the thigh for knee distraction, or between the joint and a patient positioner attached to the operating table). This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 015272206
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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 |
Other Devices Sharing Product Codes
amblersurgical.com