Identity
- Trade Name
- Total-Comfort ColorFlex Soft Tip Aspirators Orange FDA UDI
- Generic Name
- Dental suction system cannula, single-use FDA UDI
- Device Name
- combine the patented comfort of a soft elastic tip with bold bright colored tubing. Superior Italian-quality construction holds a bend without kinking. Fixed clear ends. 6” long. Phthalate-free. FDA UDI
- Model / Reference
- 70-19116 ORA FDA UDI
- Description
- combine the patented comfort of a soft elastic tip with bold bright colored tubing. Superior Italian-quality construction holds a bend without kinking. Fixed clear ends. 6” long. Phthalate-free. FDA UDI
Identifiers
- Catalog Number
- 70-19116 ORA FDA UDI
- Primary DI / UDI-DI
- 00723896009628 FDA UDI
- FDA Product Code
- EHZ FDA UDI
- GMDN Term
- Dental suction system cannula, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental suction system cannula, single-use
Total-Comfort ColorFlex Soft Tip Aspirators Orange by Practicon, 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
- Practicon, Inc.
Sources (1)
- FDA UDI 661aa746-2f25-4184-a8c5-9628080a93a8 34 fields · synced May 31, 2026