Titanium Flap Elevator

GUDID 00840096200027

Titanium Flap Elevator

KATALYST SURGICAL LLC

Periosteal elevator, reusable Periosteal elevator, reusable Periosteal elevator, reusable Periosteal elevator, reusable Periosteal elevator, reusable Periosteal elevator, reusable Periosteal elevator, reusable Periosteal elevator, reusable Periosteal elevator, reusable Periosteal elevator, reusable Periosteal elevator, reusable
Primary Device ID00840096200027
NIH Device Record Key347f62f2-ae25-4681-af18-a80ccd1f2259
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitanium Flap Elevator
Version Model Number8020
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840096200027 [Primary]
GS100840096200027 [Primary]
GS100840096200027 [Primary]
GS100840096200027 [Primary]
GS100840096200027 [Primary]
GS100840096200027 [Primary]
GS100840096200027 [Primary]
GS100840096200027 [Primary]
GS100840096200027 [Primary]
GS100840096200027 [Primary]
GS100840096200027 [Primary]

FDA Product Code

HTEElevator
HTEElevator
HTEElevator
HTEElevator
HTEElevator
HTEElevator
HTEElevator
HTEElevator
HTEElevator
HTEElevator
HTEElevator

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096200027]

Moist Heat or Steam Sterilization


[00840096200027]

Moist Heat or Steam Sterilization


[00840096200027]

Moist Heat or Steam Sterilization


[00840096200027]

Moist Heat or Steam Sterilization


[00840096200027]

Moist Heat or Steam Sterilization


[00840096200027]

Moist Heat or Steam Sterilization


[00840096200027]

Moist Heat or Steam Sterilization


[00840096200027]

Moist Heat or Steam Sterilization


[00840096200027]

Moist Heat or Steam Sterilization


[00840096200027]

Moist Heat or Steam Sterilization


[00840096200027]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-26
Device Publish Date2020-05-18

Devices Manufactured by KATALYST SURGICAL LLC

00840096207385 - Flieringa Scleral Fixation Ring, 8mm2020-06-17 Flieringa Scleral Fixation Ring, 8mm
00840096207392 - Flieringa Scleral Fixation Ring, 9mm2020-06-17 Flieringa Scleral Fixation Ring, 9mm
00840096207408 - Flieringa Scleral Fixation Ring, 10mm2020-06-17 Flieringa Scleral Fixation Ring, 10mm
00840096207415 - Flieringa Scleral Fixation Ring, 11mm2020-06-17 Flieringa Scleral Fixation Ring, 11mm
00840096207422 - Flieringa Scleral Fixation Ring, 12mm2020-06-17 Flieringa Scleral Fixation Ring, 12mm
00840096207439 - Flieringa Scleral Fixation Ring, 13mm2020-06-17 Flieringa Scleral Fixation Ring, 13mm
00840096207446 - Flieringa Scleral Fixation Ring, 14mm2020-06-17 Flieringa Scleral Fixation Ring, 14mm
00840096207453 - Flieringa Scleral Fixation Ring, 15mm2020-06-17 Flieringa Scleral Fixation Ring, 15mm

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.