FDA UDI
In Commercial Distribution
🇺🇸 United States
MAT,4 HANDLES,**SPECIAL SIZE**
DI: 00840314806581
·
Model: 3002-99
·
Hausmann Enterprises, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MAT,4 HANDLES,**SPECIAL SIZE**
- Primary DI
- 00840314806581
- Version / Model
- 3002-99
- Company Name
- Hausmann Enterprises, LLC
- Labeler DUNS
- 001892660
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-16
- Public Version
- 1
- Public Version Date
- 2022-08-24
- Public Version Status
- New
- Public Device Record Key
- a3ae2e7a-cb48-45fe-ad84-233077fcd5d7
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IOD | Components, Exercise | Physical Medicine | 890.5350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44417 | Gymnasium mat | A deviced that is placed upon the floor upon which a person can move on a soft surface intended for training and rehabilitation to regain and/or improve body movement and balance and/or for strengthening the limbs and the trunk of the body. It will typically be used by a person with a disability. It consists of a padded mat that is typically square or oblong in shape upon which the person moves around in safe, floor-level positions and/or can perform gymnastic movements. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840314806581 | GS1 |