Cylindrical Sponge

GUDID 20749915002481

Cylindrical Sponges-Strung 3/8" x 3/4"

AMERICAN SURGICAL COMPANY, LLC

Dissection sponge
Primary Device ID20749915002481
NIH Device Record Key7f5ddfa2-1452-4a56-b63e-908cf39d5fc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCylindrical Sponge
Version Model Number70-05
Company DUNS151054954
Company NameAMERICAN SURGICAL COMPANY, LLC
Device Count50
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
GS110749915002484 [Unit of Use]
GS120749915002481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFNCotton, Roll

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 Date2017-08-11

On-Brand Devices [Cylindrical Sponge]

20749915002481Cylindrical Sponges-Strung 3/8" x 3/4"
20749915001668Cylindrical Sponges-Strung 1/2" x 1.5"
20749915001651Cylindrical Sponges-Strung 3/8" x 1.5"

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