Kittner

GUDID 20749915000722

Cotton Kittner 9/16" x 1/4"

AMERICAN SURGICAL COMPANY, LLC

Dissection sponge Dissection sponge
Primary Device ID20749915000722
NIH Device Record Key427f5d75-703b-4c27-be25-3433e9af40ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameKittner
Version Model Number45-01
Company DUNS151054954
Company NameAMERICAN SURGICAL COMPANY, LLC
Device Count40
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110749915000725 [Unit of Use]
GS120749915000722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFQGauze/Sponge, Internal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-30

Devices Manufactured by AMERICAN SURGICAL COMPANY, LLC

00749915002937 - Atlas Choice Microsurgery Pattie Collection2021-12-17 Atlas Choice Microsurgery Pattie Collection
00749915002944 - Atlas Choice Cranial Pattie Collection2021-12-17 Atlas Choice Cranial Pattie Collection
10749915002842 - Tapered Delicot2021-09-03 Tapered Delicot 6 mm x 19 mm x 51 mm
10749915002866 - Tapered Delicot2021-09-03 Tapered Delicot 6 mm x 19 mm x 51 mm
10749915002880 - Tapered Delicot2021-09-03 Tapered Delicot 19 mm x 25 mm x 25 mm
10749915002903 - Tapered Delicot2021-09-03 Tapered Delicot 19 mm x 25 mm x 76 mm
20749915002733 - Tapered Delicot2021-06-09 Tapered Delicot 3 mm x 6 mm x 48 mm
10749915002767 - Tapered Delicot2021-06-09 Tapered Delicot 4 mm x 9 mm x 48 mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.