Identity
- Trade Name
- Hysolate FDA UDI
- Generic Name
- Rubber dam stabilization cord, Hevea-latex FDA UDI
- Device Name
- Wedjets Stabilization cord Latex x-small, 2.1 m FDA UDI
- Model / Reference
- H08040 FDA UDI
- Description
- Wedjets Stabilization cord Latex x-small, 2.1 m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630392900492 FDA UDI
- FDA Product Code
- EIE FDA UDI
- GMDN Term
- Rubber dam stabilization cord, Hevea-latex FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6300 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
Yes
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
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: Rubber dam stabilization cord, Hevea-latex
Hysolate by Dent4You AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rubber dam stabilization cord, Hevea-latex.
- Plasdent — PLASDENT CORP. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
Sources (1)
- FDA UDI ab7afe13-6ac8-4cac-9986-6d4976119553 34 fields · synced May 30, 2026