FDA.reportPublic FDA data

Cohesive Wrap - 2"x 5 yds

Primary DI
00766588283463
Brand
Cohesive Wrap - 2"x 5 yds
Company
Certified Safety Manufacturing, Inc.
Model
R228-346
Catalog number
R228-346
Device description
Cohesive Wrap - 2"x 5 yds
Published
2026-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940249000CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSINGCertified Safety Mfg., Inc.1994-10-03LRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766588283463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588283463007665882834637665882834630766588283463

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
788460483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00766588260112Class A 21 - Grab-N-Go Large - Red Velcro BagK626-011K626-0112026-06-04
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
00766588249810Class B 21 ANSI Plus - RTB 5186K624-981K624-9812026-03-02
0076658825009050 Person Contractors Kit - 24 Poly WhiteK625-009K625-0092026-03-02
00766588235714"607 QF Strips Plastic 1""x 3"" 16/Box"R523-571R523-5712026-02-05
00766588235998QF C-Protector Mouth-to-Mouth BarrierR523-599R523-5992026-02-05
00766588251035PG&E Field Class B 21 Plus - Jump Bag 5210K625-103K625-1032026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395360MillenniumAvalign Technologies, Inc.HTD2026-07-14
B382SD906201100Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD906202100NC0Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD91705515T0Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD91705525T0Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9183761030Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9184571000Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9184932000Surgical DirectSurgical Direct, Inc.HTD2026-07-13
00810158219960PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00810158219977PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00810158219991PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00850088713008PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00850083275174Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275181Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275198Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275204Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275211Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275228Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275518Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275730Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275747Intrace USAPILOTIS TECH LLCHTD2026-07-03
00190776421786MillenniumAvalign Technologies, Inc.HTD2026-06-24
00192896123502Stefan Bone Holding ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123519Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123526Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123533Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00810158210837PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211100PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211117PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211148PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23