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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Arthrex® - 00888867039629

NEEDLE SLEEVE, HIP PORTAL
ARTHREX, INC.
AR-6513-02
In Commercial Distribution

  • 00888867039629 ()
AR-6513-02

  • Surgical drill guide, reusable

Arthrex® - 00888867039612

ACCESS GUIDE, HIP PORTAL
ARTHREX, INC.
AR-6513-01
In Commercial Distribution

  • 00888867039612 ()
AR-6513-01

  • Surgical drill guide, reusable

Arthrex® - 00888867039407

DW CART
ARTHREX, INC.
AR-6481
Not in Commercial Distribution

  • 00888867039407 ()
AR-6481

  • Electromechanical device/system transport trolley

Arthrex® - 00888867038875

iBALANCE TKA, LMR INSTRUMENT CASE
ARTHREX, INC.
AR-605-C
In Commercial Distribution

  • 00888867038875 ()
AR-605-C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867038769

iBALANCE TKA, LMR DISTAL CUT GUIDE
ARTHREX, INC.
AR-605-1
In Commercial Distribution

  • 00888867038769 ()
AR-605-1

  • Suturing unit, single-use

Arthrex® - 00888867038721

IBALANCE TKA, PATELLA CEMENT CLAMP
ARTHREX, INC.
AR-603-85
In Commercial Distribution

  • 00888867038721 ()
AR-603-85

  • Bone approximation clamp

Arthrex® - 00888867038653

IBALANCE TKA, UNIVERSAL IMPACTOR HANDLE
ARTHREX, INC.
AR-603-31
In Commercial Distribution

  • 00888867038653 ()
AR-603-31

  • Orthopaedic implant impactor, reusable

Arthrex® - 00888867038578

iBALANCE PFJ INSTRUMENT CASE
ARTHREX, INC.
AR-602-C
In Commercial Distribution

  • 00888867038578 ()
AR-602-C

  • Endoscope video camera

Arthrex® - 00888867038561

iBALANCE PFJ, ANTERIOR CUT GUIDE
ARTHREX, INC.
AR-602-9
In Commercial Distribution

  • 00888867038561 ()
AR-602-9

  • Surgical drill guide, reusable

Arthrex® - 00888867038097

IBALANCE PFJ, FINISHING GUIDE, SIZE 4
ARTHREX, INC.
AR-602-14
In Commercial Distribution

  • 00888867038097 ()
AR-602-14

  • Surgical drill guide, reusable

Arthrex® - 00888867038080

IBALANCE PFJ, FINISHING GUIDE, SIZE 3
ARTHREX, INC.
AR-602-13
In Commercial Distribution

  • 00888867038080 ()
AR-602-13

  • Surgical drill guide, reusable

Arthrex® - 00888867038073

IBALANCE PFJ, FINISHING GUIDE, SIZE 2
ARTHREX, INC.
AR-602-12
In Commercial Distribution

  • 00888867038073 ()
AR-602-12

  • Surgical drill guide, reusable

Arthrex® - 00888867038066

IBALANCE PFJ, FINISHING GUIDE, SIZE 1
ARTHREX, INC.
AR-602-11
In Commercial Distribution

  • 00888867038066 ()
AR-602-11

  • Surgical drill guide, reusable

Arthrex® - 00888867038042

IBAL UKA,TIB SIZING GD,SZ 6,RM
ARTHREX, INC.
AR-601-TTR6
In Commercial Distribution

  • 00888867038042 ()
AR-601-TTR6

  • Suturing unit, single-use

Arthrex® - 00888867038035

IBAL UKA,TIB SIZING GD,SZ 5,RM
ARTHREX, INC.
AR-601-TTR5
In Commercial Distribution

  • 00888867038035 ()
AR-601-TTR5

  • Suturing unit, single-use

Arthrex® - 00888867038028

IBAL UKA,TIB SIZING GD,SZ 4,RM
ARTHREX, INC.
AR-601-TTR4
In Commercial Distribution

  • 00888867038028 ()
AR-601-TTR4

  • Suturing unit, single-use

Arthrex® - 00888867038011

IBAL UKA,TIB SIZING GD,SZ 3,RM
ARTHREX, INC.
AR-601-TTR3
In Commercial Distribution

  • 00888867038011 ()
AR-601-TTR3

  • Suturing unit, single-use

Arthrex® - 00888867038004

IBAL UKA,TIB SIZING GD,SZ 2,RM
ARTHREX, INC.
AR-601-TTR2
In Commercial Distribution

  • 00888867038004 ()
AR-601-TTR2

  • Suturing unit, single-use

Arthrex® - 00888867037991

IBAL UKA,TIB SIZING GD,SZ 1,RM
ARTHREX, INC.
AR-601-TTR1
In Commercial Distribution

  • 00888867037991 ()
AR-601-TTR1

  • Suturing unit, single-use

Arthrex® - 00888867037984

IBAL UKA,TIB SIZING GD,SZ 6,LM
ARTHREX, INC.
AR-601-TTL6
In Commercial Distribution

  • 00888867037984 ()
AR-601-TTL6

  • Suturing unit, single-use
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