FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Integra®
DI: 10381780265122
·
Model: SS3403
·
INTEGRA PAIN MANAGEMENT
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Integra®
- Primary DI
- 10381780265122
- Version / Model
- SS3403
- Company Name
- INTEGRA PAIN MANAGEMENT
- Labeler DUNS
- 030370299
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2024-04-05
- Public Version Status
- Update
- Public Device Record Key
- b2ec971e-3e17-469b-b8da-3544f4662cbf
- Distribution End Date
- 2023-12-04
Device Description
NERVE BLOCK PAINPAK
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
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59012 | Peripheral nerve-block blunt needle access cannula | A sterile flexible tube designed to provide percutaneous access to a peripheral nerve group for the insertion of a nerve-block blunt needle and injection of an anaesthetic/analgesic agent for nerve-block/pain control. It is typically made of plastic and contains a sharp-tipped metal needle to facilitate its introduction which may be guided by fluoroscopy. Once introduced, the sharp needle is intended to be removed so the cannula can be used as a conduit for the nerve-block blunt needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30381780265126 | GS1 | CASE | 10 | Not in Commercial Distribution | 2023-12-04 |
| Primary | 10381780265122 | GS1 | ||||
| Secondary | M610SS34031 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage Environment Temperature: 20 C to 25 C (68 F to 77 F)