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Kmedic

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
KMEDIC FDA UDI
Generic Name
Medical capital equipment storage bag/case FDA UDI
Device Name
K-WIRE STEINMANN CASE-9" K-WIRE & PINS FDA UDI
Model / Reference
IPN015737 FDA UDI
Description
K-WIRE STEINMANN CASE-9" K-WIRE & PINS FDA UDI

Identifiers

Catalog Number
KM71009 FDA UDI
Primary DI / UDI-DI
14026704722362 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
Medical capital equipment storage bag/case FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Width — 5.5 Inch FDA UDI
Length — 19.5 Inch FDA UDI
Depth — 2.5 Inch FDA UDI

Category: Medical capital equipment storage bag/case

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

Similar devices

Also classified as Medical capital equipment storage bag/case.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI ffd2237d-f545-4871-aeb3-6fdaba91a50d 36 fields · synced May 31, 2026