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FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Surgical instrument guard, single-use, sterile FDA UDI
Device Name
TwistLock(TM) Cath-Gard(R) Catheter Contamination Shield for use with 7 Fr. Catheters FDA UDI
Model / Reference
IPN035947 FDA UDI
Description
TwistLock(TM) Cath-Gard(R) Catheter Contamination Shield for use with 7 Fr. Catheters FDA UDI

Identifiers

Catalog Number
ST-09870 FDA UDI
Primary DI / UDI-DI
00801902003560 FDA UDI
510(k) Number
K895268 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Surgical instrument guard, single-use, sterile 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

Yes

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: Surgical instrument guard, single-use, sterile

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

Similar devices

Also classified as Surgical instrument guard, single-use, sterile.

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 5d5b49fe-4903-42b2-80bd-c3b40e1c0b43 36 fields · synced May 30, 2026