FDA.reportPublic FDA data

DERMABOND PRINEO

Primary DI
10705031230996
Brand
DERMABOND PRINEO
Company
ETHICON, LLC
Model
CLR222US
Catalog number
CLR222US
Device description
Dermabond Prineo Skin Closure System
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMDCutaneous tissue adhesive with mesh

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMDCutaneous Tissue Adhesive With MeshGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031230993PackageGS12In Commercial Distribution
10705031230996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503123099320705031230993
1070503123099610705031230996

GMDN Terms#

Term, Definition table
TermDefinition
Wound closure set, topicalA collection of sterile devices used to topically close easily-approximated skin edges of wounds. It typically includes a pressure-sensitive adhesive tape or mesh and a liquid adhesive, each contained within a dispensing applicator. The tape/mesh is first applied to temporarily approximate the skin edges followed by application of the liquid adhesive, over the tape/mesh, which polymerizes to affect wound closure. This set may be used to treat surgical incisions, simple lacerations, and may also be used in conjunction with deep dermal stitches. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature030 Degrees Celsius
Storage Environment Temperature086 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
829465157
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031002449MERSILENE1762G1762G2015-09-01
10705031002401MERSILENE1760G1760G2015-09-01
10705031009547MERSILENE740G740G2015-09-01
10705031045040PERMA-HANDM13TM13T2015-09-01
10705031047259NUROLONN104TN104T2015-09-01
10705031047273NUROLONN124TN124T2015-09-01
10705031049499MERSILENER495TR495T2015-09-01
10705031049642MERSILENER756GR756G2015-09-01
10705031050006PERMA-HANDSA10GSA10G2015-09-01
10705031050037PERMA-HANDSA5HSA5H2015-09-01
10705031050129PERMA-HANDSA6HSA6H2015-09-01
10705031050143PERMA-HANDSA73HSA73H2015-09-01
10705031050167PERMA-HANDSA74HSA74H2015-09-01
10705031050181PERMA-HANDSA75HSA75H2015-09-01
10705031050204PERMA-HANDSA76GSA76G2015-09-01
10705031050228PERMA-HANDSA77GSA77G2015-09-01
10705031050242PERMA-HANDSA7HSA7H2015-09-01
10705031050310PERMA-HANDSA8HSA8H2015-09-01
10705031050358PERMA-HANDSA9GSA9G2015-09-01
10705031023369PERMA-HANDC004DC004D2015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344009404MedlineMEDLINE INDUSTRIES, INC.OMD2024-03-05
20197344009401MedlineMEDLINE INDUSTRIES, INC.OMD2024-03-05
20612479267910McKessonMCKESSON MEDICAL-SURGICAL INC.OMD2023-11-13
40612479267921McKessonMCKESSON MEDICAL-SURGICAL INC.OMD2023-11-13
05036912001502LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001533LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001557LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001519LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001540LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001571LiquiBand SecureADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-05-19
05036912001656LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-03-29
05036912001663LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2023-03-29
05036912001250LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
05036912001380LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
05036912001472LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
05036912001243LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
05036912001397LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
05036912001489LiquiBand XLADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDOMD2022-05-31
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10854137001754exofin Fusion Skin Closure System SourceMark, 60cmCHEMENCE MEDICAL PRODUCTS, INC.OMD2022-05-17
10854137001808Exofin Fusion Skin Closure System SourceMark, 6cmCHEMENCE MEDICAL PRODUCTS, INC.OMD2022-05-17
00854137001603Exofin Fusion Skin Closure System, 6cmChemence Medical, Inc.OMD2022-05-13
00854137001610Exofin Fusion Skin Closure System, 6cmCHEMENCE MEDICAL PRODUCTS, INC.OMD2022-05-13
00854137001504exofin Fusion Skin Closure System, 60cmChemence Medical, Inc.OMD2022-02-14
00854137001498exofin Fusion Skin Closure System, 30cmChemence Medical, Inc.OMD2022-02-14
00854137001511exofin Fusion Skin Closure System, 60cmCHEMENCE MEDICAL PRODUCTS, INC.OMD2022-02-14
00811220032876PremierProPRESTIGE AMERITECH, LTD.OMD2020-04-29
10811220032873PremierProSVS LLCOMD2020-04-29
00854137001238Exofin Fusion Skin Closure SystemChemence Medical, Inc.OMD2017-10-25