Integra®
- Primary DI
- 10381780464952
- Brand
- Integra®
- Company
- INTEGRA PAIN MANAGEMENT
- Model
- 3405317
- Device description
- XCELL PRP (by Apex Biologix)
- Published
- 2017-12-07
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 30381780464956 | Package | GS1 | 10 | Not in Commercial Distribution |
| 10381780464952 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 30381780464956 | 30381780464956 |
| 10381780464952 | 10381780464952 |
GMDN Terms
| Term | Definition |
|---|
| General surgical procedure kit, medicated | A general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device. |
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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