FDA.reportPublic FDA data

Integra®

Primary DI
10381780087779
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3747004
Catalog number
3747004
Device description
Integra® Arcus Marginalis Dissector
Published
2018-10-26
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
GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780087779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008777910381780087779

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length260Millimeter
Width9.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898789390039GRAIVIER MID-FACE DISSECTOR LEFTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390046GRAIVIER MID-FACE DISSECTOR RIGHTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390060FRONTO MARTINS 2 ENDOFOREHEAD DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390015TREPSAT FACELIFT DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-23
00196449034512Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
06971503600209comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503600216comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602951comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602968comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602975comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602982comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602999comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603941comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603958comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603965comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603972comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
00841732129337GENERIC Surgical InstrumentsCTL Medical CorporationGDI2025-06-04
00840183523046BR Surgical, LLCBR Surgical, LLCGDI2024-03-06
00850036790013AveliRevelle Aesthetics, Inc.GDI2024-02-26
10840199523402DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533302DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533319 DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533326DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533357DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533364DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533371DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533449DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533456DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533463DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533470DissectorKOROS U.S.A., INC.GDI2024-02-06