FDA.reportPublic FDA data

Apex

Primary DI
05391529583118
Brand
Apex
Company
ORTHOXEL DESIGNATED ACTIVITY COMPANY
Model
INS-1069S
Catalog number
INS-1069S
Device description
2.5x900mm Guidewire with Ball tip
Published
2021-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
05391529583118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391529583118053915295831185391529583118

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Ambient Storage and Handling

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
646-661 3167customercare@orthoxel.com

Regulatory Flags#

DUNS number
985596830
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391529588502ApexE04-020E04-0202022-08-17
05391529582128ApexE02-000E02-0002022-08-10
05391529582135ApexE02-005E02-0052022-08-10
05391529582142ApexE02-010E02-0102022-08-10
05391529582159ApexE02-015E02-0152022-08-10
05391529582166ApexE02-020E02-0202022-08-10
05391529582173ApexLE02-000LE02-0002022-08-10
05391529588465ApexE04-000E04-0002022-02-23
05391529588472ApexE04-005E04-0052022-02-23
05391529588489ApexE04-010E04-0102022-02-23
05391529588496ApexE04-015E04-0152022-02-23
05391529588519ApexLE04-000LE04-0002022-02-23
05391529585099ApexE03-000E03-0002021-02-05
05391529585105ApexE03-005E03-0052021-02-05
05391529585112ApexE03-010E03-0102021-02-05
05391529585129ApexE03-015E03-0152021-02-05
05391529585136ApexLE03-000LE03-0002021-02-05
05391529580773ApexE01-0052019-10-01
05391529580780ApexE01-0102019-10-01
05391529580797ApexE01-0152019-10-01

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