Identity
- Trade Name
- Access Edge FDA UDI
- Generic Name
- Gingival retraction cord, non-medicated FDA UDI
- Device Name
- Access Edge prefilled retraction paste tips, 15 FDA UDI
- Model / Reference
- 360113 FDA UDI
- Description
- Access Edge prefilled retraction paste tips, 15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817051020303 FDA UDI
- FDA Product Code
- MVL FDA UDI
- GMDN Term
- Gingival retraction cord, non-medicated FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gingival retraction cord, non-medicated
Access Edge by Centrix, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction cord, non-medicated.
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- 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
- G-DENT Retraction Cord N.000 — UAB "Medicinos linija" · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Centrix, Inc.
Sources (1)
- FDA UDI 7ac62d4c-445d-45de-86aa-24e529c0612e 33 fields · synced May 30, 2026