Sterling Medical Products
- Primary DI
- 10685404000435
- Brand
- Sterling Medical Products
- Company
- APOLLO MEDICAL PRODUCTS CORP.
- Model
- 1077
- Device description
- TOURNIQUET, 1X18
- Published
- 2019-07-23
- 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 |
|---|
| 10685404000435 | Package | GS1 | 100 | In Commercial Distribution |
| 00685404000438 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10685404000435 | 10685404000435 | | |
| 00685404000438 | 00685404000438 | 685404000438 | 0685404000438 |
GMDN Terms
| Term | Definition |
|---|
| Tourniquet cuff, single-use | A band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. 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
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