FDA.reportPublic FDA data

Integra®

Primary DI
10381780364221
Brand
Integra®
Company
Ascension Orthopedics, Inc.
Model
WIRE0930501T
Catalog number
WIRE-0930-501T
Device description
Surgical Instruments - 2.0mm K-wire - Threaded
Published
2019-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXIPASSER, WIRE, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780364221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178036422110381780364221

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, single-useA sterile, long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
942377524
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
10381780240204Cadence™102030222016-08-24
10381780240211Cadence™10203023102030232016-08-24
10381780240228Cadence™10203024102030242016-08-24
10381780240235Cadence™102030252016-08-24
10381780240242Cadence™102030262016-08-24
10381780240754Cadence™10204202102042022016-08-24
10381780245612Titan™IMC096004301IMC-0960-043-012017-08-30
10381780246374Integra®OSG20000OSG-200-002017-08-30
10381780246381Integra®OSG20010POSG-200-10P2017-08-30
10381780246398Integra®OSG20010PVOSG-200-10PV2017-08-30
10381780246404Integra®OSG20020POSG-200-20P2017-08-30
10381780246411Integra®OSG20020PVOSG-200-20PV2017-08-30
10381780246428Integra®OSG20030POSG-200-30P2017-08-30
10381780246435Integra®OSG20030PVOSG-200-30PV2017-09-05
10381780246442Integra®OSG20040POSG-200-40P2017-09-05
10381780246459Integra®OSG20040PVOSG-200-40PV2017-08-30
10381780246466Integra®OSG35001OSG-350-012017-08-30
10381780246473Integra®OSG44200OSG-442-002017-09-05
10381780246480First Choice® DRUJ SystemOSG60000OSG-600-002017-09-05
10381780246497First Choice® DRUJ SystemOSG60001OSG-600-012017-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078100127HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100134HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100141HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100295IO FiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100318XMCPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078101889Jones UnionEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078110126AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078110263AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078112267Axis BeamsEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078112281Axis BeamsEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078114735Omni MTPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078114766Omni MTPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116159Omni PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116166Omni PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116180AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078119822Axis PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078123379Omni Stable AFEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078124239Lapidus Joint PrepEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078126066Lapidus Joint PrepEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078137178MetaForeEXTREMITY MEDICAL, LLCHXI2026-10-29
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-10-26
04047844130971DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-08-14
04047844130988DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-08-14
10810128464137WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-07-22
00841731135568TITANEX VILEX LLCHXI2026-05-15
00841731137319TITANEX VILEX LLCHXI2026-05-15
00841731137906TITANEXVILEX LLCHXI2026-05-15
00841731138095TITANEX VILEX LLCHXI2026-05-15
00841731142870TITANEX VILEX LLCHXI2026-05-15