Identity
- Trade Name
- COE TRAY PLASTIC™ FDA UDI
- Generic Name
- Dental impression spacer FDA UDI
- Device Name
- COE TRAY PLASTIC™ Regular set-White powder 3 lbs. (1.4kg), Liquid 1 pt. (473mL), Coe-Sep 2 2-oz. (118mL) FDA UDI
- Model / Reference
- 240013 FDA UDI
- Description
- COE TRAY PLASTIC™ Regular set-White powder 3 lbs. (1.4kg), Liquid 1 pt. (473mL), Coe-Sep 2 2-oz. (118mL) FDA UDI
Identifiers
- Catalog Number
- 240013 FDA UDI
- Primary DI / UDI-DI
- 10386040006354 FDA UDI
- FDA Product Code
- EBH FDA UDI
- GMDN Term
- Dental impression spacer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
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: Dental impression spacer
Coe Tray Plastic™ by Gc America Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Gc America Inc.
Sources (1)
- FDA UDI 320a0489-1665-4c57-80fa-3fff07fa8539 36 fields · synced May 31, 2026