Ambler Surgical
- Primary DI
- 00190660214838
- Brand
- Ambler Surgical
- Company
- AMBLER SURGICAL CORP.
- Model
- Cronin lip and nostril retractor
- Catalog number
- 71-244
- Device description
- Cronin lip and nostril retractor, 6'', flat handle
- 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 |
|---|
| KAL | RETRACTOR, ENT |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KAL | Retractor, Ent | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00190660214838 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00190660214838 | 00190660214838 | 190660214838 | 0190660214838 |
GMDN Terms
| Term | Definition |
|---|
| Hand-held dental retractor | A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. 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
- 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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