Integra®
- Primary DI
- 30381780260855
- Brand
- Integra®
- Company
- INTEGRA PAIN MANAGEMENT
- Model
- 3403051
- Device description
- SINGLE SHOT EPIDURAL TRAY
- 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 |
|---|
| 30381780260855 | Package | GS1 | 10 | In Commercial Distribution |
| 10381780260851 | Primary | GS1 | 0 | |
| M61034030511 | Secondary | HIBCC | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 30381780260855 | 30381780260855 |
| 10381780260851 | 10381780260851 |
GMDN Terms
| Term | Definition |
|---|
| Epidural anaesthesia set, medicated | A collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Storage Environment Temperature: 20 C to 25 C (68 F to 77 F) |
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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