FDA UDI
In Commercial Distribution
🇺🇸 United States
Critical Cover
DI: 10817583023091
·
Model: MS-08259-8SP
·
ALPHA PRO TECH INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- Critical Cover
- Primary DI
- 10817583023091
- Version / Model
- MS-08259-8SP
- Catalog Number
- MS-08259-8SP
- Company Name
- ALPHA PRO TECH INC
- Labeler DUNS
- 003687733
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-12-18
- Public Version
- 1
- Public Version Date
- 2020-12-28
- Public Version Status
- New
- Public Device Record Key
- 8f9db8bd-ec8a-4cf8-b7d7-64384d51f815
Device Description
Apron, AquaTrak, Black, 8" Long Ties, UNIV
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40511 | Hygiene apron, single-use | A non-sterile garment designed to be worn by healthcare staff for general protection from soiling or spills on the ventral (front) aspect of the body, and typically to prevent penetration of infectious material, during the course of work or a procedure. It is typically made of a thin plastic polymer. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817583023098 | GS1 | Case | 1 | In Commercial Distribution | |
| Primary | 10817583023091 | GS1 | ||||
| Unit of Use | 00817583023094 | GS1 |
Customer Contacts
- Phone
- 1-520-281-0127
- [email protected]