FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 10197106247907
·
Model: 28-2398D
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 10197106247907
- Version / Model
- 28-2398D
- Catalog Number
- 28-2398D
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-01
- Public Version
- 1
- Public Version Date
- 2023-05-09
- Public Version Status
- New
- Public Device Record Key
- 7fe25f6b-fd7c-4446-bfdd-c601ab2cb052
Device Description
ARTHROGRAM 2 TRAY
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OII | Arthrogram tray | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15316 | Arthrogram kit | A collection of instruments, pharmaceuticals, equipment and various supplies intended to be used to visualize a joint by radiographic study after injection of a contrast medium into the joint space. This is a reusable device after the appropriate cleaning/sterilization of the instruments/reusable products and the consumable/pharmaceutical products have been replenished. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50197106247905 | GS1 | CASE | 20 | In Commercial Distribution | |
| Primary | 10197106247907 | GS1 |