FDA.report

1.2X100MM DOUBLE TROCAR

Primary DI
00810012485845
Brand
1.2X100MM DOUBLE TROCAR
Company
BIOPRO, INC.
Model
OL10012DS
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

Related Records

Product Codes

CodeName
HTYPin, Fixation, Smooth

Product Code Classifications

CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810012485845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810012485845008100124858458100124858450810012485845

GMDN Terms

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

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 DIBrandModelCatalogPublished
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
M20923084MTP FUSION PLATE, NARROW 10 DEGREE, RIGHT230842024-03-26
M20923085MTP FUSION PLATE, NARROW 5 DEGREE, LEFT230852024-03-26

Other Devices Sharing Product Codes

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
06438394000018ActivaPin™Bioretec OyHTY2026-02-05
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