FDA UDI
In Commercial Distribution
🇺🇸 United States
PremierPro
DI: 00811220033521
·
Model: 3475
·
SVS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PremierPro
- Primary DI
- 00811220033521
- Version / Model
- 3475
- Catalog Number
- 3475
- Company Name
- SVS LLC
- Labeler DUNS
- 831375089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-14
- Public Version
- 1
- Public Version Date
- 2022-01-24
- Public Version Status
- New
- Public Device Record Key
- d11c7302-fb2d-4b53-ac36-e9b695df628d
Device Description
PremierPro exofin® Precision Pen 1.0g (1.0ml)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | General, Plastic Surgery | 878.4010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58779 | Dermal surgical adhesive/sealant applicator | A sterile applicator designed to distribute surgical adhesive/sealant for topical application to the skin for various haemostatic and/or tissue bonding uses during a surgical procedure, or as treatment for traumatic or atraumatic cutaneous wounds. It typically consists of a small plastic spout with a brush tip that is attached to a vial of adhesive which is manually squeezed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00811220033538 | GS1 | box | 12 | In Commercial Distribution | |
| Primary | 00811220033521 | GS1 |
Customer Contacts
- Phone
- 1-855-531-7699
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212246 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 30 Degrees Celsius