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Teligen

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name
TELIGEN FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
TELIGEN REDUCED ACCESS FDA UDI
Model / Reference
286006064S FDA UDI
Description
TELIGEN REDUCED ACCESS FDA UDI

Identifiers

Catalog Number
286006064S FDA UDI
Primary DI / UDI-DI
10705034604541 FDA UDI
510(k) Number
K213978 FDA UDI
FDA Product Code
HRX FDA UDI
LXH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
888.4540 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

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: Orthopaedic surgical procedure kit, non-medicated, single-use

Teligen by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Cleared under the same submission

K213978 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medos International Sàrl

Sources (1)

  • FDA UDI a3bb238a-24e9-4ae8-afa7-0ea2e3d616df 36 fields · synced May 30, 2026