Identity
- Trade Name
- SAMPLE – Knit-Pak™ Knitted Retraction Size 00 (19.7”) EUDAMEDKnit-Pak FDA UDI
- Generic Name
- Gingival retraction cord, non-medicated FDA UDI
- Device Name
- Knit-Pak EUDAMEDSAMPLE – Knit-Pak™ Knitted Retraction Size 00 (19.7”) FDA UDI
- Model / Reference
- 9007559 EUDAMEDFDA UDI
- Description
- SAMPLE – Knit-Pak™ Knitted Retraction Size 00 (19.7”) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783001921 EUDAMEDFDA UDI
- Basic UDI-DI
- 00348783Knit-Pak2Z EUDAMED
- FDA Product Code
- MVL FDA UDI
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
- GMDN Term
- Gingival retraction cord, non-medicated FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gingival retraction cord, non-medicated
Knit-Pak by Premier Dental Products Company — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction cord, non-medicated.
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- Hilo de retracción tejido Nº2 Dentaflux — J RIPOLL SL · Class I
- Hilo de retracción tejido Nº00 Dentaflux — J RIPOLL SL · Class I
- Henry Schein — HENRY SCHEIN, INC. · U
- roeko Stay-put / non-impregnated, x-fine (0), 183 cm — Coltène/Whaledent GmbH + Co. KG · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Premier Dental Products Company
Sources (2)
- FDA UDI 4ea02c00-32d2-4bfa-862d-fa4d8c0cd7e6 33 fields · synced Oct 6, 2026
- EUDAMED c075d733-9a8b-4d97-8bf9-bb066977985c 61 fields · synced Jul 9, 2026