Director Biopsy/Needle Guide/PullUp Probe Cover Kits
- Primary DI
- 00841912103232
- Brand
- Director Biopsy/Needle Guide/PullUp Probe Cover Kits
- Company
- PROTEK MEDICAL PRODUCTS, INC.
- Model
- 7217
- Published
- 2016-09-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00841912103232 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00841912103232 | 00841912103232 | 841912103232 | 0841912103232 |
GMDN Terms
| Term | Definition |
|---|
| Body-surface ultrasound imaging transducer cover | A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 965417181
- 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
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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