FDA.reportPublic FDA data

E-PACK

Primary DI
20705031234601
Brand
E-PACK
Company
Ethicon Inc.
Model
9472E
Catalog number
9472E
Device description
E-Pack Procedure Kit
Published
2015-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, surgical, polymeric
FZPCLIP, IMPLANTABLE
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
GANSUTURE, ABSORBABLE, SYNTHETIC
GAQSuture, nonabsorbable, steel, monofilament and multifilament, sterile
GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
LDFELECTRODE, PACEMAKER, TEMPORARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
FZPClip, ImplantableGeneral, Plastic Surgery2
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2
GANSuture, Absorbable, SyntheticGeneral, Plastic Surgery2
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2
LDFElectrode, Pacemaker, TemporaryCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031234608PackageGS15Not in Commercial Distribution
20705031234601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503123460830705031234608
2070503123460120705031234601

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(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
002144145
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031005235BIOPATCH415041502016-06-20
10705031005242BIOPATCH415141512016-06-20
10705031005259BIOPATCH415241522016-06-20
10705031029309ETHIBOND EXCELD8150D81502015-09-01
10705031030572ETHIBOND EXCELD8572D85722015-09-01
10705031058552ETHIBOND EXCELX997GX997G2015-09-01
10705031088351MERSILENE1765G1765G2020-04-14
10705031204553ETHIBOND EXCELD8573D85732015-09-01
10705031206403ENDOKNOTEX10GEX10G2015-09-25
10705031049703MERSILENER833HR833H2015-09-01
10705031001107BIOPATCH10150101502016-07-18
10705031001114BIOPATCH10151101512016-06-20
10705031001121BIOPATCH10152101522016-06-20
10705031036826ETHICONDW31BDW31B2015-09-01
10705031206427ENDOLOOPEZ10GEZ10G2015-09-24
10705031206458ENDOKNOTJK10GJK10G2015-09-24
10705031206465ENDOLOOPEJ10GEJ10G2015-09-24
10705031206489PDSZK10GZK10G2015-09-24
10705031206885LAPRA-TYXC200XC2002015-09-25
10705031238909ETHICOND10191D101912016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07757093001638SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001652SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001683SUTUMEDUnilene S.A.C.GAN2023-01-09
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07757093001997SUTUMEDUnilene S.A.C.GAN2023-01-09
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07757093002093SUTUMEDUnilene S.A.C.GAN2023-01-09
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07757093024767SUTUMEDUnilene S.A.C.GAW2023-01-09
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07757093024859SUTUMEDUnilene S.A.C.GAW2023-01-09
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07757093025092SUTUMEDUnilene S.A.C.GAW2023-01-09
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07757093025146SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025184SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025290SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025313SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025467SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025610SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025702SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025726SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025740SUTUMEDUnilene S.A.C.GAW2023-01-09