FDA.reportPublic FDA data

Kwire single trocar 2.5 x 150mm, Sterile

Primary DI
00810012485890
Brand
Kwire single trocar 2.5 x 150mm, Sterile
Company
BIOPRO, INC.
Model
OL15025S
Published
2019-06-12
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
HTYPin, Fixation, Smooth

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810012485890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810012485890008100124858908100124858900810012485890

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618749857
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
true
Expiration date on label
false
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
M209232580Hintermann Compressor232582026-05-22
M209232590Hintermann Distractor232592026-05-22
M20923217MTP Targeting Guide Assembly232172025-11-28
M20923227Modular Thumb Rasp Serrated 7.5MM232272025-11-28
M20923228Modular Thumb Rasp Serrated 8.5MM232282025-11-28
M20923229Modular Thumb Rasp Serrated 10.0MM232292025-11-28
M20923230Modular Thumb Rasp Serrated 11.5MM232302025-11-28
M209177990THUMB MOD HEAD TITANIUM 13MM+2177992024-06-30
M209178000THUMB MOD HEAD TITANIIUM 12MM177802024-06-30
M209178010THUMB MOD HEAD TITANIUM 12MM+2178012024-06-30
M209178060THUMB MOD HEAD TITANIUM 14MM178062024-06-30
M209178070THUMB MOD HEAD TITANIUM 14MM+2178072024-06-30
M209178080THUMB MOD HEAD TITANIUM 15MM178082024-06-30
M209178090THUMB MOD HEAD TITANIUM 15MM+2178092024-06-30
M209177980THUMB MOD HEAD TITANIUM 13MM177982024-05-30
M209230790MTP FUSION PLATE 5 DEGREE, LEFT230792024-03-26
M209230800MTP FUSION PLATE 5 DEGREE, RIGHT230802024-03-26
M209230810MTP FUSION PLATE 0 DEGREE, LEFT230812024-03-26
M209230820MTP FUSION PLATE 0 DEGREE, RIGHT230822024-03-26
M209230830MTP FUSION PLATE, NARROW 10 DEGREE, LEFT230832024-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24053613265496Steinmann PinGebr. Brasseler GmbH & Co. KGHTY2026-03-20
00888867516533Arthrex®ARTHREX, INC.HTY2026-03-13
00888867516564Arthrex®ARTHREX, INC.HTY2026-03-13
00888867516601Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543188Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543270Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543287Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543294Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543317Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543324Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543485Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543621Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543652Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543669Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543683Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543812Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543829Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543850Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543874Arthrex®ARTHREX, INC.HTY2026-03-13
24026704912432KMEDICTELEFLEX INCORPORATEDHTY2026-02-06
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06438394000025ActivaPin™Bioretec OyHTY2026-02-05
06438394000032ActivaPin™Bioretec OyHTY2026-02-05
06438394000049ActivaPin™Bioretec OyHTY2026-02-05
06438394000056ActivaPin™Bioretec OyHTY2026-02-05
06438394000063ActivaPin™Bioretec OyHTY2026-02-05
06438394000070ActivaPin™Bioretec OyHTY2026-02-05
06438394000087ActivaPin™Bioretec OyHTY2026-02-05
06438394000094ActivaPin™Bioretec OyHTY2026-02-05
06438394000100ActivaPin™Bioretec OyHTY2026-02-05