SafeSource Shoe Covers

GUDID 00850037747269

Universal Blue Shoe Covers

Safesource Direct, L.L.C.

Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover
Primary Device ID00850037747269
NIH Device Record Key66f627fc-df0c-435d-87f5-34a69f2630eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafeSource Shoe Covers
Version Model NumberSC3001
Company DUNS118070602
Company NameSafesource Direct, L.L.C.
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com
Phone3372107920
Emailgeneral@safesourcedirect.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850037747269 [Primary]
GS100850037747627 [Unit of Use]

FDA Product Code

FXPCover, Shoe, Operating-Room

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-24
Device Publish Date2023-05-16

Devices Manufactured by Safesource Direct, L.L.C.

00850037747382 - Plant Based Procedural Mask2024-04-15 Plant Based Procedural Mask ASTM Level 3 with ear loops
00850037747122 - SafeSource Direct Level 1 Surgical Mask with Ties2023-05-24 Blue ASTM 1 Surgical Mask with Ties
00850037747139 - SafeSource Direct Level 3 Surgical Mask with Ties2023-05-24 Blue ASTM Level 3 Surgical Mask with Ties
00850037747146 - SafeSource Direct Level 1 Procedure Mask with Ear Loops2023-05-24 Blue ASTM Level 1 Procedure Mask with soft ear loops
00850037747153 - SafeSource Direct Level 3 Procedure Mask with Ear Loops2023-05-24 Blue ASTM Level 3 Procedure Mask with soft ear loops
00850037747269 - SafeSource Shoe Covers2023-05-24Universal Blue Shoe Covers
00850037747269 - SafeSource Shoe Covers2023-05-24 Universal Blue Shoe Covers

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