FDA UDI
In Commercial Distribution
🇺🇸 United States
Nulife
DI: 08905159002184
·
Model: Ultra Gloves Beadless Size - 7.0
·
MRK HEALTHCARE PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nulife
- Primary DI
- 08905159002184
- Version / Model
- Ultra Gloves Beadless Size - 7.0
- Catalog Number
- ULTLUEBL
- Company Name
- MRK HEALTHCARE PRIVATE LIMITED
- Labeler DUNS
- 650986016
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-28
- Public Version
- 1
- Public Version Date
- 2023-07-06
- Public Version Status
- New
- Public Device Record Key
- 6258a49f-70e0-4bb5-9815-84c923aa68d7
Device Description
Ultra Gloves beadless are sterile and anatomically shaped medical gloves with the thumb positioned towards the palmer surface of the index finger rather than lying flat and Intended for use during surgery.
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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| 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 | 08905159002184 | GS1 |
Customer Contacts
- Phone
- +912262611111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210969 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 7.0 |