Ambler Surgical
- Primary DI
- 00190660201630
- Brand
- Ambler Surgical
- Company
- AMBLER SURGICAL CORP.
- Model
- Harken rib spreader
- Catalog number
- 45-218
- Device description
- Harken rib spreader, curved arms, 4 detachable blades: 260.0mm, 220.0mm, 62.0mm, 49.0mm, stainless steel
- 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 Codes
| Code | Name |
|---|
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00190660201630 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Rib spreader, reusable | A self-locking surgical instrument designed to force apart two adjacent ribs to permit examination or intervention in the thoracic cavity. This device will typically have two interchangeable blades at the distal end that hook over the ribs to be parted, and a ratchet mechanism along its horizontal bar to adjust the blades and maintain its set position once it has been set. It is also known as a rib retractor and is available in various designs and sizes. It is typically made of high-grade stainless steel but types used for paediatrics may be made of corrosive resistant aluminium (Al). 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
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| 00190660002237 | Ambler Surgical | Air injection cannula | 1327E | 2021-01-07 |
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| 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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