FDA UDI
In Commercial Distribution
🇺🇸 United States
Criterion Powder Free Surgical Gloves
DI: 00304040058985
·
Model: 5700636
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Criterion Powder Free Surgical Gloves
- Primary DI
- 00304040058985
- Version / Model
- 5700636
- Catalog Number
- 5700636
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2019-05-08
- Public Version
- 2
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- 072dc424-c268-49cc-9fa2-8fe07f824577
Device Description
Criterion Powder Free Surgical Gloves, Size 6.0
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KGO | Surgeon's gloves | General, Plastic Surgery | 878.4460 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47178 | Hevea-latex surgical glove, non-powdered, non-antimicrobial | A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10304040058982 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 00304040058985 | GS1 | ||||
| Unit of Use | 20304040058989 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- FALSE