FDA UDI
In Commercial Distribution
🇺🇸 United States
Knit-Pak+
DI: 00348783001815
·
Model: 9007562
·
PREMIER DENTAL PRODUCTS COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Knit-Pak+
- Primary DI
- 00348783001815
- Version / Model
- 9007562
- Company Name
- PREMIER DENTAL PRODUCTS COMPANY
- Labeler DUNS
- 014789663
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-09
- Public Version
- 1
- Public Version Date
- 2024-01-17
- Public Version Status
- New
- Public Device Record Key
- 9ab474be-8a80-4c2f-9482-3fc0198aba9a
Device Description
Premier® Knit-Pak™+ Aluminum Chloride Impregnated Retraction Cord, Brown - Size 00, Length – 100inch(254cm)
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
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVL | Cord, Retraction | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35861 | Gingival retraction cord, non-medicated | A non-medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00348783001815 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132526 | 000 |