FDA.reportPublic FDA data

T2

Primary DI
04546540556370
Brand
T2
Company
Stryker Trauma GmbH
Model
1806-3031S
Catalog number
1806-3031S
Device description
K-Wire, CoCr, Recon
Published
2020-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540556370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540556370045465405563704546540556370

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, reusableA 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length400Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
330211587
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327376210T2 ALPHA2351-0390S2351-0390S2023-12-13
07613327361797T2 ALPHA2351-3080S2351-3080S2023-05-25
07613327361803T2 ALPHA2351-3100S2351-3100S2023-05-25
07613327406153T2 ALPHA2351-3082S2351-3082S2023-05-25
07613327406184T2 ALPHA2351-3102S2351-3102S2023-05-25
07613327095548T21806-14201806-14202022-04-27
07613153179443T21896-50551896-50552022-01-31
04546540202475T21896-50351896-50352022-01-27
07613153179368T21896-50251896-50252022-01-27
07613153179375T21896-50301896-50302022-01-27
07613153179399T21896-50401896-50402022-01-27
07613153179412T21896-50451896-50452022-01-27
07613153179436T21896-50501896-50502022-01-27
07613153179467T21896-50601896-50602022-01-27
07613153179474T21896-50651896-50652022-01-27
07613153179481T21896-50701896-50702022-01-27
07613153179498T21896-50751896-50752022-01-27
07613153179504T21896-50801896-50802022-01-27
07613153179511T21896-50851896-50852022-01-27
07613153179528T21896-50901896-50902022-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091001ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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