Identity
- Trade Name
- Mixing Tips FDA UDI
- Generic Name
- Pharmaceutical fluid-dispensing system FDA UDI
- Device Name
- 100 INTRAORAL TIPS UNIVERSAL/NDS FDA UDI
- Model / Reference
- 150100 FDA UDI
- Description
- 100 INTRAORAL TIPS UNIVERSAL/NDS FDA UDI
Identifiers
- Catalog Number
- 150100 FDA UDI
- Primary DI / UDI-DI
- D6581501001 FDA UDI
- 510(k) Number
- K955932 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Pharmaceutical fluid-dispensing system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pharmaceutical fluid-dispensing system
Mixing Tips by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K955932 also covers:
- COE® — Gc America Inc.
- EXA Advanced — Gc America Inc.
- EXA Advanced — Gc America Inc.
- EXA Advanced — Gc America Inc.
- EXA Advanced — Gc America Inc.
- EXA Advanced — Gc America Inc.
- EXA Advanced — Gc America Inc.
- EXA Advanced — Gc America Inc.
- EXAFAST™ — Gc America Inc.
- EXAFAST™ — Gc America Inc.
- EXAFAST™ — Gc America Inc.
- EXAFAST™ — Gc America Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Gc America Inc.
Sources (1)
- FDA UDI ac114470-0db6-447d-87e3-076ce4497aa5 36 fields · synced May 30, 2026