FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780357872
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
1079
Catalog number
10-79
Device description
"Integra® Miltex® Grooved Director 4-1/2"", with Probe Point and Tongue Tie"
Published
2017-06-28
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
FGMPROBE AND DIRECTOR, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780357872PrimaryGS10
H83410791SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178035787210381780357872

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological directorA slender, rod-like surgical instrument made of metal, typically with groove running along the centre of it distal shaft and/or continuing with an elongated malleable wire loop, that is used to guide other devices or instruments into a selected intracorporeal location during a gastroenterological/urological (GU) procedure. The distal shaft may be straight or curved and the proximal handle formed as a finger grip. This is a reusable device.

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780541585CODMAN® ACCU-FLO®82620282-62022024-05-29
10381780541738CODMAN®82304882-30482024-05-29
10381780536918CODMAN® ACCU-FLO®82152082-15202024-05-29
10381780536925CODMAN® ACCU-FLO®82152182-15212024-05-29
10381780537373CODMAN®82409582-40952024-05-29
10381780537380CODMAN®82859182-85912024-05-29
10381780541578CODMAN® ACCU-FLO®82620182-62012024-05-29
10381780541745CODMAN®82304982-30492024-05-29
10381780090977Integra®961020096102002018-10-26
10381780075073Integra®165002516500252018-09-17
10381780075080Integra®165003016500302018-09-17
10381780075097Integra®165005016500502018-09-17
10381780518525CODMAN® HAKIM®82300782-30072020-06-02
10381780518532CODMAN® HAKIM®82300882-30082020-06-02
10381780518600CODMAN® HAKIM®82301582-30152020-06-02
10381780518716CODMAN® HAKIM®82302682-30262020-06-02
10381780518761CODMAN® HAKIM®82303582-30352020-06-02
10381780518808CODMAN® HAKIM®82303982-30392020-06-02
10381780518976CODMAN® HAKIM®82308282-30822020-06-02
10381780519010CODMAN® HAKIM®82308682-30862020-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435875MillenniumAvalign Technologies, Inc.FGM2026-09-30
00190776427825MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427832MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427849MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427856MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427863MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427870MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427887MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427894MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427900MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427917MillenniumAvalign Technologies, Inc.FGM2026-08-26
00192896122826Barr ProbeSONTEC INSTRUMENTS, INC.FGM2026-03-10
00190776416201MillenniumAvalign Technologies, Inc.FGM2026-02-12
00192896122543Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00192896122550Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00190776411831MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411848MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411855MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411862MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411879MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411886MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411893MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411909MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776406325MillenniumAvalign Technologies, Inc.FGM2025-07-21
G453332312160PEAK MEDICALPeak Medical Distribution Inc.FGM2025-06-17
00190776399993MillenniumAvalign Technologies, Inc.FGM2025-06-03
04049047024422GimmiGimmi GmbHFGM2025-05-06
G4533352001180PEAK MEDICALPeak Medical Distribution Inc.FGM2025-01-20
G586G91027310Novo SurgicalNOVO SURGICAL, INC.FGM2024-10-15
04049197272230RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-09-20