FDA.reportPublic FDA data

ETHICON

Primary DI
10705031135208
Brand
ETHICON
Company
Johnson & Johnson Medical GmbH
Model
EH40
Catalog number
EH40
Device description
Purse string Clamp Reusable
Published
2018-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705031135208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503113520810705031135208

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266customersupport@eesus.jnj.com

Regulatory Flags#

DUNS number
324368661
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031468948Coated VICRYLJ321HJ321H2026-07-24
10705031085862ULTRAPROUML1UML12019-01-25
10705031202795ARTISYNARTYARTY2019-01-29
10705031468641Coated VICRYLJ1036HJ1036H2022-06-27
10705031468672Coated VICRYLJ216HJ216H2022-06-27
10705031469075Coated VICRYLJ330HJ330H2022-06-27
10705031469723Coated VICRYLJ9441GJ9441G2022-07-11
10705031040274Coated VICRYLJ473HJ473H2015-09-01
10705031040335Coated VICRYLJ479HJ479H2015-09-01
10705031134195EndopathE705RLE705RL2016-07-01
10705031135451EndopathSRNH1LSRNH1L2016-07-01
10705031039117Coated VICRYLJ346HJ346H2015-09-01
10705031040373Coated VICRYLJ485HJ485H2015-09-01
10705031462892Coated VICRYLJV1069HJV1069H2022-12-28
30705031469727Coated VICRYLJ9441GJ9441G2022-07-11
30705031468645Coated VICRYLJ1036HJ1036H2022-06-27
30705031468676Coated VICRYLJ216HJ216H2022-06-27
30705031469079Coated VICRYLJ330HJ330H2022-06-27
10705031135178EndopathE705RE705R2016-07-01
10705031135444EndopathSRNH1SRNH12016-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776432911MillenniumAvalign Technologies, Inc.GCJ2026-09-30
00190776432928MillenniumAvalign Technologies, Inc.GCJ2026-09-30
B382SD13768330Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD9156321100Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD49195170Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
B382SD9039841050Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268329Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268336Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268343Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268374Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268381Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268398Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268404Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268411Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268459Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268466Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268473Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268480Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268497Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268503Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269517Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269531Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269548Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25