FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDICAL APRON
DI: 08809783490327
·
Model: SA-2001MA
·
UNICO GLOBAL INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- MEDICAL APRON
- Primary DI
- 08809783490327
- Version / Model
- SA-2001MA
- Company Name
- UNICO GLOBAL INC
- Labeler DUNS
- 690513726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-03-18
- Public Version
- 1
- Public Version Date
- 2022-03-28
- Public Version Status
- New
- Public Device Record Key
- b183f9e3-82c0-472d-a19a-daeaff6ad677
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35778 | Surgical apron, single-use | A sterile garment designed to be worn by surgical staff for protection from soiling or spills on the ventral (front) aspect of the body during surgical procedures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08809783490372 | GS1 | ||||
| Primary | 08809783490327 | GS1 |