FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 00612479241992
·
Model: 169-10-0919
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- McKesson
- Primary DI
- 00612479241992
- Version / Model
- 169-10-0919
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-22
- Public Version
- 2
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- 97b37c37-06d2-4e81-8410-0f61bb4e8648
Device Description
Therapy Putty soft resistance level 1 lb
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ION | Exerciser, Non-Measuring | Physical Medicine | 890.5370 | 1 |
| IOD | Components, Exercise | Physical Medicine | 890.5350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34200 | Finger/hand exerciser | A non-powered device intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity, density, magnetism, or other means. It is available in a variety of forms including handgrips (some types with individual buttons to work each finger independently), elastic balls and webs, putty, and hand-held devices with elastic bands. The device may also help improve finger/hand flexibility and coordination, and help improve wrist and forearm strength. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00612479242005 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00612479241992 | GS1 |