Integra®
- Primary DI
- 30381780431903
- Brand
- Integra®
- Company
- INTEGRA PAIN MANAGEMENT
- Model
- INS7040
- Catalog number
- INS7040
- Device description
- Integra® Cranial Access Kit
- Published
- 2017-11-03
- 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 |
|---|
| 30381780431903 | Package | GS1 | 5 | In Commercial Distribution |
| 10381780263913 | Previous | GS1 | 0 | |
| 10381780431909 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 30381780431903 | 30381780431903 |
| 10381780263913 | 10381780263913 |
| 10381780431909 | 10381780431909 |
GMDN Terms
| Term | Definition |
|---|
| Manual cranial rotary handpiece, single-use | A manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Do Not Use If Package Is Damaged |
| 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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