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Silex

FDA UDI

Class II (US FDA UDI)

by Silex Medical, Llc

Identity

Trade Name
Silex FDA UDI
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Device Name
Slide Locking Fundus Tri-Max Grasping Forceps FDA UDI
Model / Reference
EZL-1050 FDA UDI
Description
Slide Locking Fundus Tri-Max Grasping Forceps FDA UDI

Identifiers

Primary DI / UDI-DI
B331EZL1050 FDA UDI
510(k) Number
K914910 FDA UDI
K933387 FDA UDI
K946263 FDA UDI
FDA Product Code
GEI FDA UDI
GCJ FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
876.1500 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Silex by Silex Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K914910 also covers:

K933387 also covers:

K946263 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Silex Medical, Llc

Sources (1)

  • FDA UDI 3c363bf7-64d0-4a6e-b3a4-6536a37e2f48 35 fields · synced Jun 8, 2026