FDA.reportPublic FDA data

PremierPro

Primary DI
10811220032873
Brand
PremierPro
Company
SVS LLC
Model
3474
Catalog number
3474
Device description
EXOFINFUSION® Skin Closure System, 30cm
Published
2020-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10811220032873PackageGS12In Commercial Distribution
00811220032876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081122003287310811220032873
00811220032876008112200328768112200328760811220032876

GMDN Terms#

Term, Definition table
TermDefinition
Dermal surgical adhesive/sealant applicatorA sterile applicator designed to distribute surgical adhesive/sealant for topical application to the skin for various haemostatic and/or tissue bonding uses during a surgical procedure, or as treatment for traumatic or atraumatic cutaneous wounds. It typically consists of a small plastic spout with a brush tip that is attached to a vial of adhesive which is manually squeezed. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-531-7699udi@s2s-global.com

Regulatory Flags#

DUNS number
831375089
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811220035495PremierPro882088202024-10-28
00811220035518PremierPro882188212024-10-28
10811220035430PremierProD5061D50612024-03-08
10811220035447PremierProD5062D50622024-03-08
10811220035454PremierProD5063D50632024-03-08
10811220035461PremierProD5064D50642024-03-08
10811220035478PremierProD5065D50652024-03-08
00811220035143PremierProFL1003DFL1003D2024-02-14
00811220035174PremierProFL1005DFL1005D2024-02-14
00811220035099PremierProFL1010DFL1010D2024-02-14
00811220035112PremierProFL1010SFFL1010SF2024-02-14
00811220034412PremierPro™31T1417531T141752022-12-19
00811220034443PremierPro™31T1617731T161772022-12-19
00811220034474PremierPro™31T1811631T181162022-12-19
00811220034504PremierPro™31T1818831T181882022-12-19
00811220034535PremierPro™31T2011631T201162022-12-19
00811220034566PremierPro™31T2010031T201002022-12-19
00811220034597PremierPro™31T2018831T201882022-12-19
00811220034627PremierPro™31T2210031T221002022-12-19
00811220034658PremierPro™31T2407531T240752022-12-19

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
00854137001757exofin Fusion Skin Closure System SourceMark, 60cmChemence Medical, Inc.OMD2022-05-17
00854137001801Exofin Fusion Skin Closure System SourceMark, 6cmChemence Medical, Inc.OMD2022-05-17
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
00854137001238Exofin Fusion Skin Closure SystemChemence Medical, Inc.OMD2017-10-25
10854137001235Exofin Fusion Skin Closure SystemCHEMENCE MEDICAL PRODUCTS, INC.OMD2017-10-25