Identity
- Trade Name
- Intacs Sterile Vacuum Tubing FDA UDI
- Generic Name
- Suction/irrigation tubing, single-use FDA UDI
- Device Name
- Single use disposable vacuum tubing set to be used as an accessory to the Addition Technology, Inc and Kera Vision Vacuum System. FDA UDI
- Model / Reference
- 7K6000 FDA UDI
- Description
- Single use disposable vacuum tubing set to be used as an accessory to the Addition Technology, Inc and Kera Vision Vacuum System. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866304000142 FDA UDI
- FDA Product Code
- GAZ FDA UDI
- GMDN Term
- Suction/irrigation tubing, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Suction/irrigation tubing, single-use
Intacs Sterile Vacuum Tubing by Addition Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suction/irrigation tubing, single-use.
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- Suction Tube Ch 24, 350 cm — Dispo Medical B.V. · Class I
- Bioseal Inc. — BIOSEAL · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Addition Technology
Sources (1)
- FDA UDI af7596dd-2724-4131-9d1f-b2f670732afc 33 fields · synced Jun 8, 2026