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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 Procedure Kit Pro FDA UDI
Model / Reference
186000000S FDA UDI
Description
TELIGEN Procedure Kit Pro FDA UDI

Identifiers

Catalog Number
186000000S FDA UDI
Primary DI / UDI-DI
10705034560359 FDA UDI
510(k) Number
K213978 FDA UDI
K223108 FDA UDI
K223438 FDA UDI
FDA Product Code
PDQ FDA UDI
LXH FDA UDI
HRX FDA UDI
GAD FDA UDI
OLO FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.1820 FDA UDI
888.4540 FDA UDI
888.1100 FDA UDI
878.4800 FDA UDI
882.4560 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:

K223108 also covers:

K223438 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 5e696ca9-f9d5-4663-a373-0ef7d92b90c0 36 fields · synced May 30, 2026