FDA UDI
In Commercial Distribution
🇺🇸 United States
Safety Max Diamond
DI: 00850048332898
·
Model: SMD-35-XL
·
Pristine Dental Supplies, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Safety Max Diamond
- Primary DI
- 00850048332898
- Version / Model
- SMD-35-XL
- Company Name
- Pristine Dental Supplies, Inc.
- Labeler DUNS
- 080057154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-03-30
- Public Version
- 1
- Public Version Date
- 2023-04-07
- Public Version Status
- New
- Public Device Record Key
- 7666417a-a771-4121-b6e6-2592a66e3247
Device Description
XLARGE Nitrile Medical Examination Gloves, Textured, Powder free, latex free, Violet Blue
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LZA | Polymer Patient Examination Glove | General Hospital | 880.6250 | 1 |
| LZC | Medical Glove, Specialty | General Hospital | 880.6250 | 1 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60908 | Sterilization container liner | A non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. 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 | 00850048332881 | GS1 | ||||
| Primary | 00850048332898 | GS1 |