FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780498711
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
22-500TC
Catalog number
22-500TC
Device description
"Integra® Miltex® Wire Twister, 6"", Tungsten Carbide"
Published
2018-09-18
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
HXSTWISTER, WIRE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXSTwister, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780498711PrimaryGS10
H83422500TC0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178049871110381780498711

GMDN Terms#

Term, Definition table
TermDefinition
Wire twisterA surgical instrument specifically designed to twist surgical wire after this has been applied to the site in order to tighten the loop or binding that has been made by the surgeon. The loose ends of the wire are inserted into and gripped by the jaws of this device, and the surgeon pulls a handle which spins the spirally grooved centre piece, thereby twisting and tightening the wire. It is typically used in orthopaedic procedures. 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
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
09348811105868INKAThe Trustee for KAISER FAMILY TRUSTHXS2026-06-02
09348811166029INKAThe Trustee for KAISER FAMILY TRUSTHXS2026-05-29
04052536085330neon3Ulrich GmbH & Co. KGHXS2026-05-28
04052536085361neon3Ulrich GmbH & Co. KGHXS2026-05-28
B8034803200ORTHOMEDORTHO-MED, INC.HXS2026-04-16
B8034803220ORTHOMEDORTHO-MED, INC.HXS2026-04-16
B8034803240ORTHOMEDORTHO-MED, INC.HXS2026-04-16
00888867500730Arthrex®ARTHREX, INC.HXS2026-03-13
00888867500747Arthrex®ARTHREX, INC.HXS2026-03-13
09348811105875INKAThe Trustee for KAISER FAMILY TRUSTHXS2025-11-26
04052536081097uCentumUlrich GmbH & Co. KGHXS2025-07-29
04052536081103uCentumUlrich GmbH & Co. KGHXS2025-07-29
04052536010585uCentumUlrich GmbH & Co. KGHXS2025-07-24
00190776394073MillenniumAvalign Technologies, Inc.HXS2025-05-06
00192896121379Wire TwisterSONTEC INSTRUMENTS, INC.HXS2025-04-11
00190776387372MillenniumAvalign Technologies, Inc.HXS2024-09-09
04049197086950RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXS2024-06-25
00192896116887Axel Wire Twister/CutterSONTEC INSTRUMENTS, INC.HXS2024-03-08
00888515056404BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204638BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204645BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204652BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204669BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204683BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
10840199532510Rod Holder ClampKOROS U.S.A., INC.HXS2024-01-31
00840199532513Rod Holder ClampKOROS U.S.A., INC.HXS2024-01-31
G586N2567460Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
G586N8716610Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
G586N98716620Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
00192896115828Wire TwisterSONTEC INSTRUMENTS, INC.HXS2023-11-16