FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra®
DI: 10381780431909
·
Model: INS7040
·
INTEGRA PAIN MANAGEMENT
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Integra®
- Primary DI
- 10381780431909
- Version / Model
- INS7040
- Catalog Number
- INS7040
- Company Name
- INTEGRA PAIN MANAGEMENT
- Labeler DUNS
- 030370299
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-03
- Public Version
- 4
- Public Version Date
- 2023-04-17
- Public Version Status
- Update
- Public Device Record Key
- 5a917353-725f-4189-9aa1-3aff1304ac84
Device Description
Integra® Cranial Access Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46281 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30381780431903 | GS1 | CASE | 5 | In Commercial Distribution | |
| Primary | 10381780431909 | GS1 | ||||
| Previous | 10381780263913 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Use If Package Is Damaged
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit