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Elmed

FDA UDI

Class II (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Device Name
5MM, 45CM, CLEAR FLUSH, DEBAKEY GRASPER, 60MM JAW, RADEL INSULATION, ROTABLE, ONE PIECE FDA UDI
Model / Reference
5-0545-160B FDA UDI
Description
5MM, 45CM, CLEAR FLUSH, DEBAKEY GRASPER, 60MM JAW, RADEL INSULATION, ROTABLE, ONE PIECE FDA UDI

Identifiers

Catalog Number
5-0545-160B FDA UDI
Primary DI / UDI-DI
00842180145221 FDA UDI
510(k) Number
K181173 FDA UDI
FDA Product Code
GCJ FDA UDI
GEI FDA UDI
GMDN Term
Rigid endoscopic tissue manipulation forceps, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
878.4400 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Elmed by Elmed Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K181173 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 510ba85f-b2a4-4a14-bfff-0ad90782a113 37 fields · synced Jun 1, 2026