Preminum All-Gauze Sponges ENC416

GUDID 50732224004308

4" x 4", 16 Ply

CROSSTEX INTERNATIONAL, INC.

Woven gauze pad
Primary Device ID50732224004308
NIH Device Record Keyd12db787-504d-47e8-8d01-b3cc2b3fd31a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreminum All-Gauze Sponges
Version Model NumberENC416
Catalog NumberENC416
Company DUNS057728685
Company NameCROSSTEX INTERNATIONAL, INC.
Device Count200
DM Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224004303 [Unit of Use]
GS110732224004300 [Primary]
GS150732224004308 [Package]
Contains: 10732224004300
Package: case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFQGAUZE/SPONGE, INTERNAL
NABGauze / Sponge,Nonresorbable For External Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-25
Device Publish Date2023-07-17

On-Brand Devices [Preminum All-Gauze Sponges]

507322240043084" x 4", 16 Ply
507322240042924" x 4", 12 Ply
507322240042854" x 4", 8 Ply
507322240042783" x 3", 12 Ply
507322240042613" x 3", 8 Ply
507322240042542" x 2", 12 Ply

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