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Teleflex

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
TELEFLEX FDA UDI
Generic Name
Incision/drainage kit FDA UDI
Model / Reference
IPN001797 FDA UDI

Identifiers

Catalog Number
M8811 FDA UDI
Primary DI / UDI-DI
10841156110963 FDA UDI
FDA Product Code
GCB 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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

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

Similar devices

Also classified as Incision/drainage kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 377176aa-1750-49fe-ab1c-be7eafdfb528 34 fields · synced Jun 8, 2026