FDA.reportPublic FDA data

E-PACK

Primary DI
10705031012776
Brand
E-PACK
Company
Ethicon Inc.
Model
8124E
Catalog number
8124E
Device description
E-Pack Kits
Published
2015-09-24
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
GAQSuture, nonabsorbable, steel, monofilament and multifilament, sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705031012776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503101277610705031012776

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Away from moisture and direct heat
Storage Environment Temperature025 Degrees Celsius
Storage Environment Temperature077 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002144145
Device count
1
Kit
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
30652927785303DemeSTEELDEMETECH CORPORATIONGAQ2023-08-22
30652927786089DemeSTEELDEMETECH CORPORATIONGAQ2023-08-22
30652927786096DemeSTEELDEMETECH CORPORATIONGAQ2023-08-22
10848782046000ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046017ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046024ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046031ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046048ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046055ValkyrieSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046307FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046314FSSBSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046321FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046338FSSBSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046345FSSBSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046352FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046369FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046376FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
10848782046383FumedicaSurgical Specialties México, S. de R.L. de C.V.GAQ2022-12-27
30652927777827DemeSTEELDemetech CorporationGAQ2022-12-21
30652927782920DemeSTEELDemetech CorporationGAQ2022-12-21
30652927783170DemeSTEELDemetech CorporationGAQ2022-12-21
30652927783187DemeSTEELDemetech CorporationGAQ2022-12-21
30652927783194DemeSTEELDemetech CorporationGAQ2022-12-21
30652927783200DemeSTEELDemetech CorporationGAQ2022-12-21
10861445000300CoNextions TR Tendon Repair System-Combo KitCONEXTIONS MEDICAL INCGAQ2022-04-28
10861445000317CoNextions TR Tendon Repair System-Deployment MechanismCONEXTIONS MEDICAL INCGAQ2022-04-28
10861445000324CoNextions TR Tendon Repair System-Implant MechanismCONEXTIONS MEDICAL INCGAQ2022-04-28
10814639025047UNIFY Stainless Surgical SuturesAPPLIED DENTAL, INC.GAQ2021-01-15
10814639025054UNIFY Stainless Surgical SuturesAPPLIED DENTAL, INC.GAQ2021-01-15
30652927722698DemeSTEELDEMETECH CORPORATIONGAQ2020-10-13