FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780442318
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
30-2109TC
Catalog number
30-2109TC
Device description
"Integra® Miltex® Parametrium Scissors, 12"", Tungsten Carbide, Slightly Curved"
Published
2018-02-05
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
LRWSCISSORS, GENERAL, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780442318PrimaryGS10
H834302109TC0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178044231810381780442318

GMDN Terms#

Term, Definition table
TermDefinition
Gynaecological scissors, reusableA hand-held manual surgical instrument designed to cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use. It is comprised of two pivoted shearing blades with finger and thumb ring-handles (i.e., not pinch-grip design) whereby the shearing action is directly adjacent to the handles (i.e., not alligator or endoscopic design). It is made of metal and available in a variety of blade designs; the blades may have carbide inserts along the cutting edges. 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
10381780156802Integra® Ruggles®-Redmond™RN2528RN25282016-08-14
10381780167075Integra® Jarit®500105500-1052018-04-09
10381780394761Integra® Jarit®500100500-1002018-04-09
10381780394778Integra® Jarit®500110500-1102018-04-09
10381780394808Integra® Jarit®500135500-1352018-04-09
10381780435860Integra® Miltex®30-3030-302018-01-24
10381780435907Integra® Miltex®30-5530-552018-01-24
10381780435952Integra® Miltex®30-6230-622018-01-24
10381780488248Integra® Miltex®MH30-10MH30-102018-08-20
10381780488262Integra® Miltex®MH30-15MH30-152018-08-20
10381780488279Integra® Miltex®MH30-20MH30-202018-08-20
10381780488286Integra® Miltex®MH30-30MH30-302018-08-20
10381780488293Integra® Miltex®MH30-50MH30-502018-08-20
10381780488361Integra® Miltex®MH30-55MH30-552018-08-20
10381780488378Integra® Miltex®MH30-60MH30-602018-08-20
10381780488385Integra® Miltex®MH30-62MH30-622018-08-20
10381780500490Integra® Miltex®30-1030-102018-09-18
10381780500520Integra® Miltex®30-1530-152018-09-18
10381780500605Integra® Miltex®30-2030-202018-09-18
10381780077244Integra®371231037123102018-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995268848Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268855Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268862Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268879Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268886Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268893Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268909Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00190776432355MillenniumAvalign Technologies, Inc.LRW2026-09-24
00810238290001PRINCETONPrinceton Medical Group, Inc.LRW2026-09-22
00190776427979MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428013MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428136MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428204MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428235MillenniumAvalign Technologies, Inc.LRW2026-08-27
00192896123649Converse ScissorsSONTEC INSTRUMENTS, INC.LRW2026-08-27
00192896123656Ferguson Abdominal ScissorsSONTEC INSTRUMENTS, INC.LRW2026-08-27
00190776423865MillenniumAvalign Technologies, Inc.LRW2026-08-26
00190776423872MillenniumAvalign Technologies, Inc.LRW2026-08-26
00190776427634MillenniumAvalign Technologies, Inc.LRW2026-08-26
00846159040845SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00846159040852SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00846159040869SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00190776420383MillenniumAvalign Technologies, Inc.LRW2026-08-25
04058749006032NAFehling Instruments GmbH & Co. KGLRW2026-08-25
04058749047219NAFehling Instruments GmbH & Co. KGLRW2026-08-25
00190776427283MillenniumAvalign Technologies, Inc.LRW2026-08-21
04054462903290evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904624evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904631evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904655evonosevonos GmbH & Co. KGLRW2026-08-21