FDA UDI
In Commercial Distribution
🇺🇸 United States
Medical Action Industries
DI: 10809160015582
·
Model: 710-B
·
MEDICAL ACTION INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Medical Action Industries
- Primary DI
- 10809160015582
- Version / Model
- 710-B
- Company Name
- MEDICAL ACTION INDUSTRIES INC.
- Labeler DUNS
- 092364462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 4
- Public Version Date
- 2019-06-07
- Public Version Status
- Update
- Public Device Record Key
- e0bcfcf1-0101-495c-8ccc-9c0aa19f7ea1
Device Description
Towel: OR Blu 80/Cs
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KKX | Drape, surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45171 | Dry medical towel/wipe, single-use | A dry fabric intended to be used to wipe or dry a patient’s intact skin (not related to wound care), clean medical devices/equipment (e.g., endoscopes, ultrasound systems), and/or clean the general environment (e.g., fluid spill). It may be moistened (e.g., with water or used together with disinfectant/cleaning solutions) however no solutions are included. Some devices may be provided sterile, or designed to be sterilized, for use under sterile conditions [e.g., within an operating room (OR)]; devices intended for non-surgical applications may be provided and used in a non-sterile state. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20809160015589 | GS1 | 8 | In Commercial Distribution | ||
| Primary | 10809160015582 | GS1 | ||||
| Unit of Use | 40809160015583 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature
- Type
- Special Storage Condition, Specify