FDA UDI
In Commercial Distribution
🇺🇸 United States
Curity
DI: 10884521020344
·
Model: 1017
·
Cardinal Health, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Curity
- Primary DI
- 10884521020344
- Version / Model
- 1017
- Catalog Number
- 1017
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2023-08-16
- Public Version Status
- Update
- Public Device Record Key
- 22554942-cf75-42a8-b2fc-abdd9ffb7b09
Device Description
Adult Lumbar Puncture Tray with Safety Components,Spinal Needle with Stylet
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMJ | MANOMETER, SPINAL-FLUID | General Hospital | 880.2500 | 2 |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12404 | Lumbar puncture kit | A collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521020341 | GS1 | CASE | 20 | In Commercial Distribution | |
| Primary | 10884521020344 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Needle Gauge,18,Gauge; | ||
| Length | 3.5 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry;AVOID DIRECT SUNLIGHT