FDA.reportPublic FDA data

E-PACK

Primary DI
10705031204799
Brand
E-PACK
Company
Ethicon Inc.
Model
9125E
Catalog number
9125E
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
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
10705031204799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503120479910705031204799

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
10705031462571VISTASEALVSTL35VSTL352019-10-01
10705031462724VISTASEALVSTL45VSTL452019-10-01
10705031462533VISTASEALVSTAS1VSTAS1, VSTAS1E2019-10-01
10705031131958ETHICONMS1995MS19952015-09-23
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

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Primary DI, Brand, Company table
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10705031097643PROLENEETHICON, LLCGAW2026-08-17
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