Integra®
- Primary DI
- 30381780264341
- Brand
- Integra®
- Company
- INTEGRA PAIN MANAGEMENT
- Model
- PITRW1735
- Device description
- Epidural Steroid Injection Needles
- 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 |
|---|
| 30381780264341 | Package | GS1 | 10 | In Commercial Distribution |
| 10381780264347 | Primary | GS1 | 0 | |
| M610PITRW17351 | Secondary | HIBCC | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 30381780264341 | 30381780264341 |
| 10381780264347 | 10381780264347 |
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. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Regulatory Flags
- DUNS number
- 030370299
- 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
- true
- Sterilization required before use
- false
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