FDA UDI
In Commercial Distribution
🇺🇸 United States
ABSORB-O-MAT
DI: 00880304403314
·
Model: 902105
·
Biomet Orthopedics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ABSORB-O-MAT
- Primary DI
- 00880304403314
- Version / Model
- 902105
- Catalog Number
- 902105
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-23
- Public Version
- 1
- Public Version Date
- 2020-06-01
- Public Version Status
- New
- Public Device Record Key
- fab412ef-6373-4ccc-9e64-7d5b7303dbc9
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRL | FIBER, MEDICAL, ABSORBENT | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44011 | Decontamination floor mat, single-use | A pad made of coarse, durable material that is designed to be placed on the floor to wipe the soles of the footwear of persons walking on its surface. The product is intended to reduce the distribution of dirt/contaminated materials on the floor. The product is for single-use and is not washed or cleaned for reuse. It may be a pad of layered adhesive sheets that bind dirt touching the surface; when the sheet is sufficiently saturated it is peeled off and discarded to reveal a new adhesive surface. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00880304403314 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 48 IN. X 48 IN. |