FDA UDI
In Commercial Distribution
🇺🇸 United States
PERFORMANCE HEALTH
DI: 00840216115903
·
Model: A8515
·
Asp Global, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PERFORMANCE HEALTH
- Primary DI
- 00840216115903
- Version / Model
- A8515
- Company Name
- Asp Global, LLC
- Labeler DUNS
- 080361159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-24
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 26905033-f626-424b-af09-1d10d70de1ff
Device Description
Jamar 9-Hole Peg Test Kit, Jamar 9-Hole Peg Test Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- Has Manufacturing Date
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63958 | Manual dexterity test | A non-powered, non-electronic device in the form of a simple game/test intended to help assess the fine manual/finger dexterity of a patient suspected of having, or diagnosed with, a neuromuscular disorder (e.g., multiple sclerosis). It is often in the form of a nine-hole peg test whereby the patient is intended to place/remove nine wooden pegs in nine individual holes as quickly as possible; repeated testing may help indicate changes in manual dexterity. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840216115903 | GS1 |