Identity
- Trade Name
- Turkel FDA UDI
- Generic Name
- Aspiration tray, single-use FDA UDI
- Device Name
- Pneumothorax Procedure Tray with Safety Components,8 Fr/Ch x 3-1/2 inch (2.7 mm x 8.9 cm) Catheter FDA UDI
- Model / Reference
- 8888567032 FDA UDI
- Description
- Pneumothorax Procedure Tray with Safety Components,8 Fr/Ch x 3-1/2 inch (2.7 mm x 8.9 cm) Catheter FDA UDI
Identifiers
- Catalog Number
- 8888567032 FDA UDI
- Primary DI / UDI-DI
- 10884521020627 FDA UDI
- 510(k) Number
- K934428 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- Aspiration tray, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 8 French FDA UDILength — 3.50 Inch FDA UDI
Category: Aspiration tray, single-use
Turkel by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aspiration tray, single-use.
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- Jet-Vac Procedure Trays — PFM MEDICAL INCORPORATED · Class I
- MICROLYZER — T-BIYOTEKNOLOJI LABORATUVAR ESTETIK MEDIKAL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI · Class I
- Jet-Vac Procedure Trays — PFM MEDICAL INCORPORATED · Class I
- Safe-T-Centesis — CAREFUSION 2200, INC. · Class II
- PercuSet Basic Biopsy Tray — Bracco Diagnostics Inc. · Class I
- Jet-Vac Procedure Trays — PFM MEDICAL INCORPORATED · 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
- Cardinalhealth
Sources (1)
- FDA UDI 673b9ec4-8ea6-413c-b0ae-0d80cfabf658 38 fields · synced May 31, 2026