Sterling Medical Products
- Primary DI
- 10685404000442
- Brand
- Sterling Medical Products
- Company
- APOLLO MEDICAL PRODUCTS CORP.
- Model
- 1106
- Device description
- AMNIOCENTESIS TRAY
- Published
- 2019-09-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10685404000442 | Package | GS1 | 20 | In Commercial Distribution |
| 00685404000445 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10685404000442 | 10685404000442 | | |
| 00685404000445 | 00685404000445 | 685404000445 | 0685404000445 |
GMDN Terms
| Term | Definition |
|---|
| Amniocentesis kit, medicated, single-use | A collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, dressings, and pharmaceuticals. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. This is a single-use device. |
Regulatory Flags
- DUNS number
- 116768422
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
sterlingmedproducts.com