Sterling Medical Products
- Primary DI
- 10685404001012
- Brand
- Sterling Medical Products
- Company
- APOLLO MEDICAL PRODUCTS CORP.
- Model
- N1194
- Device description
- STERILE VAGINAL SPECULUM
- Published
- 2019-07-17
- 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 |
|---|
| 10685404001012 | Package | GS1 | 30 | In Commercial Distribution |
| 00685404001015 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10685404001012 | 10685404001012 | | |
| 00685404001015 | 00685404001015 | 685404001015 | 0685404001015 |
GMDN Terms
| Term | Definition |
|---|
| Vaginal speculum, single-use | A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. 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