FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterling Medical Products
DI: 00685404002852
·
Model: SS335
·
APOLLO MEDICAL PRODUCTS CORP.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Sterling Medical Products
- Primary DI
- 00685404002852
- Version / Model
- SS335
- Company Name
- APOLLO MEDICAL PRODUCTS CORP.
- Labeler DUNS
- 116768422
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-13
- Public Version
- 1
- Public Version Date
- 2024-05-21
- Public Version Status
- New
- Public Device Record Key
- e1963907-eb7e-4d79-b350-a30420badb92
Device Description
STERILE NITRILE GLOVES, LG, PAIR
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60660 | Nitrile examination/treatment glove, non-powdered, antimicrobial | A device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe transmission/exposure and its inner surface is not covered with powder. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. 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 | 10685404002859 | GS1 | CARTON | 50 | In Commercial Distribution | |
| Primary | 00685404002852 | GS1 |
Customer Contacts
- Phone
- 8155375303
- [email protected]