18M - Burn Relief K203-031

GUDID 00766588030319

18M - Burn Relief

Certified Safety Manufacturing, Inc.

Burn kit, medicated
Primary Device ID00766588030319
NIH Device Record Key2e7e8afc-44c6-47aa-b5da-a3ccd2e59ed9
Commercial Distribution StatusIn Commercial Distribution
Brand Name18M - Burn Relief
Version Model NumberK203-031
Catalog NumberK203-031
Company DUNS788460483
Company NameCertified Safety Manufacturing, Inc.
Device Count1
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100766588030319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRRFirst Aid Kit with drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-22
Device Publish Date2024-03-14

Devices Manufactured by Certified Safety Manufacturing, Inc.

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00766588110172 - 639 - Certi-Gauze Compress - 36"x 36" - 1/Unit2024-11-07 639 - Certi-Gauze Compress - 36"x 36" - 1/Unit
00766588110219 - 640 - Certi-Gauze Compress - 24"x 72" - 1/Unit2024-11-07 640 - Certi-Gauze Compress - 24"x 72" - 1/Unit
00766588110301 - 628 - Certi-Non-Stick Pads - 2"x 3" - 4/Unit2024-11-07 628 - Certi-Non-Stick Pads - 2"x 3" - 4/Unit
00766588310039 - Certi-Non Stick Pads - 2"x 3" - 25/Box2024-11-07 Certi-Non Stick Pads - 2"x 3" - 25/Box
00766588312057 - Certi-Gauze Pads - 3"x 3" - 100/Box2024-11-07 Certi-Gauze Pads - 3"x 3" - 100/Box
00766588312095 - Certi-Gauze Pads - 2"x 2" - 25/Box2024-11-07 Certi-Gauze Pads - 2"x 2" - 25/Box

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