Capsule Polishing Curette

GUDID 00840096200140

KATALYST SURGICAL LLC

Ophthalmic curette, reusable
Primary Device ID00840096200140
NIH Device Record Key2f3560e4-6604-466c-9f4e-0ee2a446f81e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapsule Polishing Curette
Version Model Number1
Company DUNS007883297
Company NameKATALYST SURGICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840096200140 [Primary]

FDA Product Code

FZSCurette, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096200140]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-01
Device Publish Date2019-06-21

On-Brand Devices [Capsule Polishing Curette ]

008400962001401
00840096205848Capsule Polishing Curette

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