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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® - 00888867037977

IBAL UKA,TIB SIZING GD,SZ 5,LM
ARTHREX, INC.
AR-601-TTL5
In Commercial Distribution

  • 00888867037977 ()
AR-601-TTL5

  • Suturing unit, single-use

Arthrex® - 00888867037960

IBAL UKA,TIB SIZING GD,SZ 4,LM
ARTHREX, INC.
AR-601-TTL4
In Commercial Distribution

  • 00888867037960 ()
AR-601-TTL4

  • Suturing unit, single-use

Arthrex® - 00888867037953

IBAL UKA,TIB SIZING GD,SZ 3,LM
ARTHREX, INC.
AR-601-TTL3
In Commercial Distribution

  • 00888867037953 ()
AR-601-TTL3

  • Suturing unit, single-use

Arthrex® - 00888867037946

IBAL UKA,TIB SIZING GD,SZ 2,LM
ARTHREX, INC.
AR-601-TTL2
In Commercial Distribution

  • 00888867037946 ()
AR-601-TTL2

  • Suturing unit, single-use

Arthrex® - 00888867037939

IBAL UKA,TIB SIZING GD,SZ 1,LM
ARTHREX, INC.
AR-601-TTL1
In Commercial Distribution

  • 00888867037939 ()
AR-601-TTL1

  • Suturing unit, single-use

Arthrex® - 00888867037908

iBALANCE UKA, RESECTION GUIDE, RIGHT
ARTHREX, INC.
AR-601-TRRM
In Commercial Distribution

  • 00888867037908 ()
AR-601-TRRM

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867037892

iBALANCE UKA, RESECTION GUIDE, LEFT
ARTHREX, INC.
AR-601-TRLM
In Commercial Distribution

  • 00888867037892 ()
AR-601-TRLM

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867037830

iBALANCE UKA, TIBIAL ALIGNMENT GUIDE
ARTHREX, INC.
AR-601-TG00
In Commercial Distribution

  • 00888867037830 ()
AR-601-TG00

  • Suturing unit, single-use

Arthrex® - 00888867037311

IBAL UKA,POST RESECT GD,10MM
ARTHREX, INC.
AR-601-PB10
In Commercial Distribution

  • 00888867037311 ()
AR-601-PB10

  • Suturing unit, single-use

Arthrex® - 00888867037304

IBAL UKA,POST RESECT GD,9MM
ARTHREX, INC.
AR-601-PB09
In Commercial Distribution

  • 00888867037304 ()
AR-601-PB09

  • Suturing unit, single-use

Arthrex® - 00888867037298

IBAL UKA,POST RESECT GD,8MM
ARTHREX, INC.
AR-601-PB08
In Commercial Distribution

  • 00888867037298 ()
AR-601-PB08

  • Suturing unit, single-use

Arthrex® - 00888867037281

IBAL UKA,POST RESCTION GD,7MM
ARTHREX, INC.
AR-601-PB07
In Commercial Distribution

  • 00888867037281 ()
AR-601-PB07

  • Suturing unit, single-use

Arthrex® - 00888867037274

IBAL UKA,POST RESECT GD,6MM
ARTHREX, INC.
AR-601-PB06
In Commercial Distribution

  • 00888867037274 ()
AR-601-PB06

  • Suturing unit, single-use

Arthrex® - 00888867037267

IBAL UKA,POST RESECT GD,5MM
ARTHREX, INC.
AR-601-PB05
In Commercial Distribution

  • 00888867037267 ()
AR-601-PB05

  • Suturing unit, single-use

Arthrex® - 00888867037250

IBAL UKA,POST RESECT GD,4MM
ARTHREX, INC.
AR-601-PB04
In Commercial Distribution

  • 00888867037250 ()
AR-601-PB04

  • Suturing unit, single-use

Arthrex® - 00888867037243

IBAL UKA,POST RESECT GD,3MM
ARTHREX, INC.
AR-601-PB03
In Commercial Distribution

  • 00888867037243 ()
AR-601-PB03

  • Suturing unit, single-use

Arthrex® - 00888867036994

IBAL UKA,CHAMFER & PEG GD,SZ 6,RM/LL
ARTHREX, INC.
AR-601-CRMF
In Commercial Distribution

  • 00888867036994 ()
AR-601-CRMF

  • Arthroscopic shaver system blade, reusable

Arthrex® - 00888867036987

IBAL UKA,CHAMFER & PEG GD,SZ 5,RM/LL
ARTHREX, INC.
AR-601-CRME
In Commercial Distribution

  • 00888867036987 ()
AR-601-CRME

  • Bone lever/elevator, reusable

Arthrex® - 00888867036970

IBAL UKA,CHAMFER & PEG GD,SZ 4,RM/LL
ARTHREX, INC.
AR-601-CRMD
In Commercial Distribution

  • 00888867036970 ()
AR-601-CRMD

  • Bone lever/elevator, reusable

Arthrex® - 00888867036963

IBAL UKA,CHAMFER & PEG GD,SZ 3,RM/LL
ARTHREX, INC.
AR-601-CRMC
In Commercial Distribution

  • 00888867036963 ()
AR-601-CRMC

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867036956

IBAL UKA,CHAMFER & PEG GD,SZ 2,RM/LL
ARTHREX, INC.
AR-601-CRMB
In Commercial Distribution

  • 00888867036956 ()
AR-601-CRMB

  • Suturing unit, reusable

Arthrex® - 00888867036949

IBAL UKA,CHAMFER & PEG GD,SZ 1,RM/LL
ARTHREX, INC.
AR-601-CRMA
In Commercial Distribution

  • 00888867036949 ()
AR-601-CRMA

  • Surgical instrument handle, non-torque-limiting

Arthrex® - 00888867036925

IBAL UKA,CHAMFER & PEG GD,SZ 6,LM/RL
ARTHREX, INC.
AR-601-CLMF
In Commercial Distribution

  • 00888867036925 ()
AR-601-CLMF

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867036918

IBAL UKA,CHAMFER & PEG GD,SZ 5,LM/RL
ARTHREX, INC.
AR-601-CLME
In Commercial Distribution

  • 00888867036918 ()
AR-601-CLME

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867036901

IBAL UKA,CHAMFER & PEG GD,SZ 4,LM/RL
ARTHREX, INC.
AR-601-CLMD
In Commercial Distribution

  • 00888867036901 ()
AR-601-CLMD

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867036895

IBAL UKA,CHAMFER & PEG GD,SZ 3,LM/RL
ARTHREX, INC.
AR-601-CLMC
In Commercial Distribution

  • 00888867036895 ()
AR-601-CLMC

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867036888

IBAL UKA,CHAMFER & PEG GD,SZ 2,LM/RL
ARTHREX, INC.
AR-601-CLMB
In Commercial Distribution

  • 00888867036888 ()
AR-601-CLMB

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867036871

IBAL UKA,CHAMFER & PEG GD,SZ 1,LM/RL
ARTHREX, INC.
AR-601-CLMA
In Commercial Distribution

  • 00888867036871 ()
AR-601-CLMA

  • Orthopaedic fixation implant alignment tool

Arthrex® - 00888867036864

IBALANCE UKA INSTRUMENT CASE
ARTHREX, INC.
AR-601-C2
In Commercial Distribution

  • 00888867036864 ()
AR-601-C2

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867036857

IBALANCE UKA INSTRUMENT CASE
ARTHREX, INC.
AR-601-C1
In Commercial Distribution

  • 00888867036857 ()
AR-601-C1

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867036840

IBALANCE UKA, BONE CALIPER
ARTHREX, INC.
AR-601-BC00
In Commercial Distribution

  • 00888867036840 ()
AR-601-BC00

  • Suturing unit, single-use

Arthrex® - 00888867036819

600 PWR SYS BASKET HOLDER INSTR CS
ARTHREX, INC.
AR-600GC
In Commercial Distribution

  • 00888867036819 ()
AR-600GC

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867036802

600 PWR 2 HAND PIECE&BATTERY HOUSING CS
ARTHREX, INC.
AR-600C-3
In Commercial Distribution

  • 00888867036802 ()
AR-600C-3

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867036796

600 PWR SYS INTRUMENT CS W/2 HAND PIECES
ARTHREX, INC.
AR-600C-2
In Commercial Distribution

  • 00888867036796 ()
AR-600C-2

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867036789

600 POWER SYSTEM INSTRUMENT CASE
ARTHREX, INC.
AR-600C
In Commercial Distribution

  • 00888867036789 ()
AR-600C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867035997

CHONDROGUARD DRILL GUIDE HIP, 6MM OFFSET
ARTHREX, INC.
AR-5600-02
In Commercial Distribution

  • 00888867035997 ()
AR-5600-02

  • Surgical drill guide, reusable

Arthrex® - 00888867035980

CHONDROGUARD DRILL GUIDE HIP, 4MM OFFSET
ARTHREX, INC.
AR-5600-01
In Commercial Distribution

  • 00888867035980 ()
AR-5600-01

  • Surgical drill guide, reusable

Arthrex® - 00888867035942

PARALLEL PIN GUIDE
ARTHREX, INC.
AR-5503
In Commercial Distribution

  • 00888867035942 ()
AR-5503

  • Suturing unit, single-use

Arthrex® - 00888867035935

FEMORAL COLLATERAL MARKING HOOK
ARTHREX, INC.
AR-5502
In Commercial Distribution

  • 00888867035935 ()
AR-5502

  • Soft-tissue surgical hook, reusable

Arthrex® - 00888867035928

TIBIAL COLLATERAL MARKING HOOK
ARTHREX, INC.
AR-5501
In Commercial Distribution

  • 00888867035928 ()
AR-5501

  • Soft-tissue surgical hook, reusable
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