FDA.report

E-PACK

Primary DI
10705031009486
Brand
E-PACK
Company
ETHICON INC.
Model
7395E
Catalog number
7395E
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
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GAQSuture, nonabsorbable, steel, monofilament and multifilament, sterile

Product Code Classifications

CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20705031009483PackageGS15Not in Commercial Distribution
10705031009486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2070503100948320705031009483
1070503100948610705031009486

GMDN Terms

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

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

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags

DUNS number
002144145
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DIBrandModelCatalogPublished
30705031471218ETHIZIAHSP510HSP5102026-01-16
10705031000865GYNECARE THERMACHOICE00825008252014-09-20
20705031003306J-VAC216121612015-09-23
20705031003313J-VAC216221622015-09-23
20705031003320J-VAC216321632015-09-23
30705031078486Coated VICRYLVCP496ZHVCP496ZH2023-01-09
30705031470105Coated VICRYLVCP496ZGVCP496ZG2023-01-09
10705031228139ETHICONEVRC67EVRC672015-09-23
30705031078080Coated VICRYLVCP392ZHVCP392ZH2023-02-06
20705031003467BLAKE221022102015-09-23
20705031003474BLAKE221122112015-09-23
20705031003481BLAKE221222122015-09-23
20705031003498BLAKE221322132015-09-23
20705031003504BLAKE221422142015-09-23
20705031003511BLAKE221522152015-09-23
20705031003528BLAKE221622162015-09-23
20705031003535BLAKE221722172015-09-23
20705031003542BLAKE222622262015-09-23
20705031003559BLAKE222722272015-09-23
20705031003566BLAKE222822282015-09-23

Other Devices Sharing Product Codes

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