FDA UDI
In Commercial Distribution
🇺🇸 United States
Birkova
DI: 00724995211752
·
Model: Armboard Pads
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Birkova
- Primary DI
- 00724995211752
- Version / Model
- Armboard Pads
- Catalog Number
- AS65812PM
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 036985604
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-30
- Public Version
- 1
- Public Version Date
- 2021-07-08
- Public Version Status
- New
- Public Device Record Key
- 8aaba731-67e3-4abb-a61e-6d3708ffbdcf
Device Description
Multiposition Armboard Pad 21 inches x 5.5 inches x 2 inches, PM Series
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LWG | SURGICAL TABLE CUSHION | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41141 | Arm cushion | A soft pillow or pad used to provide support and comfort to the user's arm, typically during the treatment and/or prevention of musculoskeletal or circulatory disorders (e.g., muscle sprain/strain, lymphoedema). The device may be used to support various areas of the arm (i.e., wrist, elbow, or shoulder). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995211752 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]