AK-Control.Sil -2 mm-

FDA UDI

Class I (US FDA UDI)

by Streifeneder ortho.production GmbH

Identity

Trade Name: AK-Control.Sil -2 mm- FDA UDI
Generic Name: External limb prosthesis socket liner FDA UDI
Device Name: AK-ControlSil -2 mm-, size 50, silicone liner with distal connection, outer matrix without silicone strips, antibacterial finish FDA UDI
Model / Reference: 60L50/50 FDA UDI
Description: AK-ControlSil -2 mm-, size 50, silicone liner with distal connection, outer matrix without silicone strips, antibacterial finish FDA UDI

Identifiers

Catalog Number: 60L50/50 FDA UDI
Primary DI / UDI-DI: 04048817625623 FDA UDI
FDA Product Code: ISS FDA UDI
GMDN Term: External limb prosthesis socket liner FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: External limb prosthesis socket liner

AK-Control.Sil -2 mm- by Streifeneder ortho.production GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Streifeneder ortho.production GmbH

Sources (1)

FDA UDI 8ef28e38-aaa1-4b97-9aaa-c0e9b942f939 35 fields · synced Jun 1, 2026