25ga DEX™ Stiff Slim Maculorhexis Forceps

GUDID 00840096213010

25ga DEX™ Stiff Slim Maculorhexis Forceps

KATALYST SURGICAL LLC

Ophthalmic soft-tissue manipulation forceps, probe-like, single-use
Primary Device ID00840096213010
NIH Device Record Key8083394a-8c46-4134-8031-6583e205105c
Commercial Distribution StatusIn Commercial Distribution
Brand Name25ga DEX™ Stiff Slim Maculorhexis Forceps
Version Model NumberDVFO4019-25-S
Company DUNS007883297
Company NameKATALYST SURGICAL LLC
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840096213010 [Unit of Use]
GS110840096213017 [Primary]

FDA Product Code

HNKProbe, Trabeculotomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-29
Device Publish Date2020-09-21

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