Integra®
- Primary DI
- 30381780355995
- Brand
- Integra®
- Company
- INTEGRA PAIN MANAGEMENT
- Model
- TRAPJTD1110-15-IMA
- Device description
- Trapsystem Bone Marrow Biopsy & Aspiration Tray
- Published
- 2016-11-23
- 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 |
|---|
| 30381780355995 | Package | GS1 | 10 | Not in Commercial Distribution |
| 10381780355991 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 30381780355995 | 30381780355995 |
| 10381780355991 | 10381780355991 |
GMDN Terms
| Term | Definition |
|---|
| Bone marrow biopsy procedure kit | A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. 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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