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FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Incision/drainage kit FDA UDI
Device Name
Cath-Gard(R) Catheter Contamination Shield for use with Interventional Products - Percutaneous Sheath Introducers FDA UDI
Model / Reference
IPN033834 FDA UDI
Description
Cath-Gard(R) Catheter Contamination Shield for use with Interventional Products - Percutaneous Sheath Introducers FDA UDI

Identifiers

Catalog Number
AI-08803 FDA UDI
Primary DI / UDI-DI
00801902003157 FDA UDI
510(k) Number
K895268 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Incision/drainage kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Incision/drainage kit

Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Incision/drainage kit.

Cleared under the same submission

K895268 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI bfda8c6a-aa04-428d-86d9-990d05bb717d 36 fields · synced Jun 8, 2026