Identity
- Trade Name
- TAUT FDA UDI
- Generic Name
- Laparoscopic trocar blade, single-use FDA UDI
- Device Name
- 24 EA ISI DA VINCI Si 8MM LONG OBTURATOR FDA UDI
- Model / Reference
- IPN028437 FDA UDI
- Description
- 24 EA ISI DA VINCI Si 8MM LONG OBTURATOR FDA UDI
Identifiers
- Catalog Number
- 420024 FDA UDI
- Primary DI / UDI-DI
- 14026704629593 FDA UDI
- 510(k) Number
- K010007 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Laparoscopic trocar blade, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laparoscopic trocar blade, single-use
Taut by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic trocar blade, single-use.
- Xpan Universal Trocar System — Xpan, Inc. · Class II
- CORE DYNAMICS — Conmed Corporation · Class II
- WECK VISTA — Intuitive Surgical, Inc. · Class II
- WECK VISTA — Intuitive Surgical, Inc. · Class II
- CORE DYNAMICS — Conmed Corporation · Class II
- WECK VISTA — Intuitive Surgical, Inc. · Class II
- CORE DYNAMICS — Conmed Corporation · Class II
- CORE DYNAMICS — Conmed Corporation · Class II
Cleared under the same submission
K010007 also covers:
- Bladeless Laparoscopic Access Port — CooperSurgical, Inc.
- TAUT — TELEFLEX INCORPORATED
- TAUT — TELEFLEX INCORPORATED
- TAUT — TELEFLEX INCORPORATED
- TAUT — TELEFLEX INCORPORATED
- TAUT — TELEFLEX INCORPORATED
- TAUT — TELEFLEX INCORPORATED
- TAUT — TELEFLEX INCORPORATED
- TAUT — TELEFLEX INCORPORATED
- TAUT — TELEFLEX INCORPORATED
- TAUT — TELEFLEX INCORPORATED
- TAUT — TELEFLEX INCORPORATED
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
- Teleflex Incorporated
Sources (1)
- FDA UDI 99eb6a4d-d825-47b4-ad5b-221da56ef63d 36 fields · synced May 31, 2026