FDA.reportPublic FDA data

"Certi-Gauze Pads - 3""x 3"" - 25/Box"

Primary DI
00766588312118
Brand
"Certi-Gauze Pads - 3""x 3"" - 25/Box"
Company
Certified Safety Manufacturing, Inc.
Model
R231-211
Catalog number
R231-211
Device description
"Certi-Gauze Pads - 3""x 3"" - 25/Box"
Published
2023-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFQGAUZE/SPONGE, INTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9450020001X6YD, 2X6YD, 4X6YD ROLL BANDAGECertified Safety Mfg., Inc.1995-03-22EFQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766588312118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588312118007665883121187665883121180766588312118

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(816)483-9090Info@certifiedsafety.com

Regulatory Flags#

DUNS number
788460483
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00766588268590Control the Bleed PackKR626-859KR626-8592026-11-02
00766588268873Utilimaster - 10 Poly WhiteK626-887K626-8872026-10-08
00766588260143Watercraft First Aid Kit - 16 Poly WhiteK626-014K626-0142026-08-19
00766588260181Teichert Clas A 21 - 18 MetalK626-018K626-0182026-08-19
00766588260112Class A 21 - Grab-N-Go Large - Red Velcro BagK626-011K626-0112026-06-04
00766588283463Cohesive Wrap - 2"x 5 ydsR228-346R228-3462026-06-04
10766588283460Cohesive Wrap - 2"x 5 yds - UDI/10R228-346R228-3462026-06-04
00766588260037Naloxone - 16 Poly ClearK626-003K626-0032026-05-26
00766588420103Forceps - MagnifierR242-010R242-0102026-05-26
10766588420100Forceps - Magnifier UDI/10R242-010R242-0102026-05-26
00766588260099Cement Burn Cabinet - 75H 2 Shelf CabinetK626-009K626-0092026-05-04
00766588090177FAA SWA on Board PPE Bag - ZLBFK209-017FK209-0172026-04-29
00766588090160FAA SWA BioHazard Clean Up Bag - ZLBFK209-016FK209-0162026-04-16
00766588260044Class B 21 BloodBorne Pathogen - 75H CabinetK626-004K626-0042026-04-16
00766588260075So Cal Gas Wilderness Tactical Class B 21 - Jump Bag 5210K626-007K626-0072026-04-16
00766588260020Naloxone - 10 Poly WhiteK626-002K626-0022026-04-06
00766588260068Burn Dressing Large - Red Velcro BagK626-006K626-0062026-04-06
00766588247045Heat Stress - 16 Poly WhiteK624-904K624-9042025-03-24
00766588260051Burn Dressing Small - Red Velcro BagK626-005K626-0052026-03-23
00766588127675RR - UP Vehicle - 75 RefillKR612-067KR612-0672026-03-02

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10192253047523CurityCardinal Health 200, LLCEFQ2023-10-09
10192253047561CurityCardinal Health 200, LLCEFQ2023-10-09
00665973017228DukalDukal LLCEFQ2022-12-06
00665973017235DukalDukal LLCEFQ2022-12-06
00665973017242DukalDukal LLCEFQ2022-12-06
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