FDA UDI
In Commercial Distribution
🇺🇸 United States
HEPRO.US Surgical Gloves - 50 Pairs Box X-Large 8.5"
DI: 00854427007407
·
Model: CT - Surgical Latex Gloves 8.5"
·
HEPRO.US INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- HEPRO.US Surgical Gloves - 50 Pairs Box X-Large 8.5"
- Primary DI
- 00854427007407
- Version / Model
- CT - Surgical Latex Gloves 8.5"
- Company Name
- HEPRO.US INC.
- Labeler DUNS
- 080061451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2017-06-21
- Public Version
- 3
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- ebc00207-0848-4264-a56a-1a05a749146b
Device Description
HEPRO.US Surgical Gloves Sterile Latex Surgical Gloves, Non-Powder 1 Right 1 Left = 1 Pair 50pairs per Box- 10 Boxes per Case X-Large
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|---|---|
| Primary | 00854427007407 | GS1 | ||||
| Unit of Use | 85442700740702 | GS1 |