Integra®
- Primary DI
- 30381780428293
- Brand
- Integra®
- Company
- INTEGRA PAIN MANAGEMENT
- Model
- 3405276
- Device description
- Core Biopsy Tray
- Published
- 2017-07-14
- Public version status
- Update
- Distribution status
- Not 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 |
|---|
| 30381780428293 | Package | GS1 | 10 | Not in Commercial Distribution |
| 10381780428299 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 30381780428293 | 30381780428293 |
| 10381780428299 | 10381780428299 |
GMDN Terms
| Term | Definition |
|---|
| Aspiration tray, single-use | A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 20 Degrees Celsius | 25 Degrees Celsius | |
| Storage Environment Temperature | 68 Degrees Fahrenheit | 77 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 030370299
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- true
- 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
- true
- Sterilization required before use
- false
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