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FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Incision/drainage kit FDA UDI
Device Name
Percutaneous Cavity Drainage Catheterization Kit Seldinger Insertion Technique FDA UDI
Model / Reference
IPN036836 FDA UDI
Description
Percutaneous Cavity Drainage Catheterization Kit Seldinger Insertion Technique FDA UDI

Identifiers

Catalog Number
AK-01600 FDA UDI
Primary DI / UDI-DI
10801902120158 FDA UDI
510(k) Number
K895516 FDA UDI
FDA Product Code
GBX FDA UDI
GMDN Term
Incision/drainage kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 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

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

Category: Incision/drainage kit

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

Similar devices

Also classified as Incision/drainage kit.

Cleared under the same submission

K895516 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 f5a0a1c5-4839-4500-a00d-7266aa7fb8ee 36 fields · synced May 30, 2026