FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704292237
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN015733
Catalog number
KM71002
Device description
"DISP K-WIRE FOR .035"" (0.9MM) 6.25"""
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HTYPIN, FIXATION, SMOOTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070561000KMEDIC INTERNAL/EXTERNAL FIXATION DEVICESTeleflex Medical2007-05-25HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704292233Direct MarkingGS10
24026704292237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704292233040267042922334026704292233
2402670429223724026704292237

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length6.25Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29
10841156108502ONCONTROLIPN9190199458-VC-0062021-10-29
10841156108564ONCONTROLIPN9190259463-VC-0062021-10-29
10841156108601ONCONTROLIPN9190299465-VC-0062021-10-29
10841156108632ONCONTROLIPN9190329468-VC-0062022-01-20
10841156108649ONCONTROLIPN9190339471-VC-0062022-01-21
10841156108656ONCONTROLIPN9190349472-VC-0062021-10-29
10841156108663ONCONTROLIPN9190359490-VC-0062022-01-20
10841156108670ONCONTROLIPN9190159408-VC-0062021-10-29
10801902228045ARROWAK-05503AK-055032026-10-09
10801902228052ARROWSJ-05501SJ-055012026-10-09
10801902228069ARROWAB-05060-PKAB-05060-PK2026-10-09
10801902228076ARROWMP-17019-TKLMP-17019-TKL2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055662968538Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHTY2026-10-16
09353903004240FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
09353903004257FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
M791TPK1237HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
M791TPK1253HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
00840536824974PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824981PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824998PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825001PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825018PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825025PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825032PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825049PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825056PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825063PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825070PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825087PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825094PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00190776405960MillenniumAvalign Technologies, Inc.HTY2026-07-28
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436100MillenniumAvalign Technologies, Inc.HTY2026-07-22