FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Integra®
DI: 10381780264187
·
Model: PISN2260
·
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
- 10381780264187
- Version / Model
- PISN2260
- 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
- 2024-12-23
- Public Version Status
- Update
- Public Device Record Key
- 05fd2ed9-7abd-4996-82d2-1a5e5b441bda
- Distribution End Date
- 2023-12-04
Device Description
Quincke Point Long Spinal Needles
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- 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 |
|---|---|---|---|---|
| 12404 | Lumbar puncture kit | A collection of devices intended for transient percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to obtain a sample of cerebrospinal fluid (CSF). Typical components include a spinal needle and collection tubes for the CSF; a drainage catheter is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30381780264181 | GS1 | BOX | 10 | Not in Commercial Distribution | 2023-12-04 |
| Primary | 10381780264187 | GS1 | ||||
| Secondary | M610PISN22601 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 22G X 6" |