FDA UDI
In Commercial Distribution
🇺🇸 United States
PremierPro
DI: 00818566013545
·
Model: 3302
·
PRESTIGE AMERITECH, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- PremierPro
- Primary DI
- 00818566013545
- Version / Model
- 3302
- Catalog Number
- 3302
- Company Name
- PRESTIGE AMERITECH, LTD.
- Labeler DUNS
- 199692794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-04
- Public Version
- 3
- Public Version Date
- 2026-03-23
- Public Version Status
- Update
- Public Device Record Key
- f3038439-d165-4ab1-9157-2939d8cb94b9
Device Description
Lubricating Jelly, 4oz Flip Top Tube, Sterile
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
- Yes
- 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 |
|---|---|---|---|---|
| KMJ | Lubricant, Patient | General Hospital | 880.6375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60796 | General-body orifice lubricant | A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818566013542 | GS1 | box | 12 | In Commercial Distribution | |
| Primary | 00818566013545 | GS1 | ||||
| Package | 20818566013549 | GS1 | case | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-855-531-7699
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius