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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SuperMX NiTi Staple w/ Instrs, 18W x 18L
ARTHREX, INC.
AR-8719MXDS-1818
In Commercial Distribution

  • 00888867300880 ()
AR-8719MXDS-1818

  • Orthopaedic bone staple, non-adjustable
SuperMX NiTi Staple w/ Instrs, 18W x 15L
ARTHREX, INC.
AR-8719MXDS-1815
In Commercial Distribution

  • 00888867300873 ()
AR-8719MXDS-1815

  • Orthopaedic bone staple, non-adjustable
SuperMX NiTi Staple w/ Instrs, 15W x 15L
ARTHREX, INC.
AR-8719MXDS-1515
In Commercial Distribution

  • 00888867300866 ()
AR-8719MXDS-1515

  • Orthopaedic bone staple, non-adjustable
DynaNite™ Nitinol Staple Sizing Guide
ARTHREX, INC.
AR-8717T
In Commercial Distribution

  • 00888867300842 ()
AR-8717T

  • Surgical depth gauge, reusable
2.2MM DRILL, CANNULATED
ARTHREX, INC.
AR-4157DB
In Commercial Distribution

  • 00888867300835 ()
AR-4157DB

  • Cannulated surgical drill bit, reusable
1.5MM HEX DRIVER, CANNULATED
ARTHREX, INC.
AR-4157D
In Commercial Distribution

  • 00888867300828 ()
AR-4157D

  • Surgical screwdriver, reusable
TAP FOR RETROFUSION SCREW
ARTHREX, INC.
AR-4157T
In Commercial Distribution

  • 00888867300811 ()
AR-4157T

  • Bone tap, reusable
DISPOSABLE INSTRUMENT KIT
ARTHREX, INC.
AR-1941DS
In Commercial Distribution

  • 00888867300781 ()
AR-1941DS

  • Arthroscopic surgical procedure kit, non-medicated, single-use
PUNCH/TAP FOR 3.9MM KNOTLESS CRKSCRW
ARTHREX, INC.
AR-1941PTB
In Commercial Distribution

  • 00888867300774 ()
AR-1941PTB

  • Orthopaedic implant impactor, reusable
FISHMOUTH SPEAR, 3.9MM KNOTLESS CRKSCRW
ARTHREX, INC.
AR-1941DGF
In Commercial Distribution

  • 00888867300767 ()
AR-1941DGF

  • Surgical drill guide, reusable
CIRC. TEETH GUIDE, 3.9MM KNOTLESS CRKSCW
ARTHREX, INC.
AR-1941CT
In Commercial Distribution

  • 00888867300750 ()
AR-1941CT

  • Surgical drill guide, reusable
GUIDE PIN, 2.4 MM
ARTHREX, INC.
AR-1250SB-1S
In Commercial Distribution

  • 00888867300712 ()
AR-1250SB-1S

  • Fluted surgical drill bit, single-use
iBal TKA Fem, PS Cemented, Sz 8, Left
ARTHREX, INC.
AR-526-8L
In Commercial Distribution

  • 00888867300408 ()
AR-526-8L

  • Unicondylar knee prosthesis
iBal TKA Fem, PS Cemented, Sz 7, Right
ARTHREX, INC.
AR-526-7R
In Commercial Distribution

  • 00888867300392 ()
AR-526-7R

  • Unicondylar knee prosthesis
iBal TKA Fem, PS Cemented, Sz 7, Left
ARTHREX, INC.
AR-526-7L
In Commercial Distribution

  • 00888867300385 ()
AR-526-7L

  • Unicondylar knee prosthesis
iBal TKA Fem, PS Cemented, Sz 6, Left
ARTHREX, INC.
AR-526-6L
In Commercial Distribution

  • 00888867300361 ()
AR-526-6L

  • Unicondylar knee prosthesis
iBal TKA Fem, PS Cemented, Sz 5, Left
ARTHREX, INC.
AR-526-5L
In Commercial Distribution

  • 00888867300347 ()
AR-526-5L

  • Unicondylar knee prosthesis
iBal TKA Fem, PS Cemented, Sz 4, Left
ARTHREX, INC.
AR-526-4L
In Commercial Distribution

  • 00888867300323 ()
AR-526-4L

  • Unicondylar knee prosthesis
iBal TKA Fem, PS Cemented, Sz 3, Right
ARTHREX, INC.
AR-526-3R
In Commercial Distribution

  • 00888867300316 ()
AR-526-3R

  • Unicondylar knee prosthesis
iBal TKA Fem, PS Cemented, Sz 3, Left
ARTHREX, INC.
AR-526-3L
In Commercial Distribution

  • 00888867300309 ()
AR-526-3L

  • Unicondylar knee prosthesis
iBal TKA Fem, PS Cemented, Sz 2, Left
ARTHREX, INC.
AR-526-2L
In Commercial Distribution

  • 00888867300286 ()
AR-526-2L

  • Unicondylar knee prosthesis
iBal TKA Fem, PS Cemented, Sz 1, Left
ARTHREX, INC.
AR-526-1L
In Commercial Distribution

  • 00888867300262 ()
AR-526-1L

  • Unicondylar knee prosthesis
iBal TKA Fem, PS Cemented, Sz 10, Right
ARTHREX, INC.
AR-526-10R
In Commercial Distribution

  • 00888867300255 ()
AR-526-10R

  • Unicondylar knee prosthesis
iBal TKA Fem, PS Cemented, Sz 10, Left
ARTHREX, INC.
AR-526-10L
In Commercial Distribution

  • 00888867300248 ()
AR-526-10L

  • Unicondylar knee prosthesis
NanoScope Probe
ARTHREX, INC.
AR-10100N
In Commercial Distribution

  • 00888867300200 ()
AR-10100N

  • Endoscopic surgical probe
33 +4 LAT/28 Glenosphere
ARTHREX, INC.
AR-9564-2833-LAT
In Commercial Distribution

  • 00888867299672 ()
AR-9564-2833-LAT

  • Total reverse shoulder prosthesis
NANOSCOPE CONSOLE
ARTHREX, INC.
AR-3200-0030
In Commercial Distribution

  • 00888867299580 ()
AR-3200-0030

  • Endoscope video camera
TRIMANO Fortis Knee Kit
ARTHREX, INC.
1002.34A0
In Commercial Distribution

  • 10888867299563 ()
  • 00888867299566 ()
1002.34A0

  • Orthopaedic knee/leg holder liner
TRIMANO Fortis Reusable Leg Holder
ARTHREX, INC.
1002.33A0
Not in Commercial Distribution

  • 00888867299559 ()
1002.33A0

  • Leg procedure positioner
iBalance TKA, Lig Bal System Set
ARTHREX, INC.
AR-634-S
In Commercial Distribution

  • 00888867299153 ()
AR-634-S

  • Orthopaedic prosthesis implantation positioning instrument, reusable
MENISCAL CINCH™ II
ARTHREX, INC.
AR-4501
In Commercial Distribution

  • 00888867299139 ()
AR-4501

  • Tendon/ligament bone anchor, non-bioabsorbable
Baseplate Extractor
ARTHREX, INC.
AR-9659-R
In Commercial Distribution

  • 00888867298675 ()
AR-9659-R

  • Orthopaedic inorganic implant inserter/extractor, reusable
Speed Guide Screw Replacement
ARTHREX, INC.
AR-9630-S
In Commercial Distribution

  • 00888867298613 ()
AR-9630-S

  • Joint prosthesis implantation kit, reusable
Speed Guide. Nonlocking Screw 28
ARTHREX, INC.
AR-9630-28NL
In Commercial Distribution

  • 00888867298606 ()
AR-9630-28NL

  • Joint prosthesis implantation kit, reusable
Speed Guide, Nonlocking Screw 24
ARTHREX, INC.
AR-9630-24NL
In Commercial Distribution

  • 00888867298590 ()
AR-9630-24NL

  • Joint prosthesis implantation kit, reusable
Baseplate Inserter, Cannulated
ARTHREX, INC.
AR-9623-C
In Commercial Distribution

  • 00888867298521 ()
AR-9623-C

  • Orthopaedic inorganic implant inserter/extractor, reusable
Baseplate Inserter
ARTHREX, INC.
AR-9623
In Commercial Distribution

  • 00888867298514 ()
AR-9623

  • Orthopaedic inorganic implant inserter/extractor, reusable
Glenosphere Sizing Guide
ARTHREX, INC.
AR-9664-SG
In Commercial Distribution

  • 00888867298316 ()
AR-9664-SG

  • Joint prosthesis implantation kit, reusable
2.8mm Guide Pin
ARTHREX, INC.
AR-9616
In Commercial Distribution

  • 00888867298279 ()
AR-9616

  • Surgical drill guide, reusable
FIBERTAPE KINGFIR,SR HNDL W/ FP
ARTHREX, INC.
AR-13971SRF
In Commercial Distribution

  • 00888867298071 ()
AR-13971SRF

  • Suturing unit, reusable
FIBERTAPE KINGFIR,NR HNDL W/ FP
ARTHREX, INC.
AR-13971NRF
In Commercial Distribution

  • 00888867298064 ()
AR-13971NRF

  • Suturing unit, reusable
FIBERTAPE KINGFIR W/ WB HNDL
ARTHREX, INC.
AR-13971W
In Commercial Distribution

  • 00888867298057 ()
AR-13971W

  • Suturing unit, reusable
FIBERTAPE KINGFIR W/ SR HNDL
ARTHREX, INC.
AR-13971SR
In Commercial Distribution

  • 00888867298040 ()
AR-13971SR

  • Suturing unit, reusable
FIBERTAPE KINGFIR W/ NR HNDL
ARTHREX, INC.
AR-13971NR
In Commercial Distribution

  • 00888867298033 ()
AR-13971NR

  • Suturing unit, reusable
1.8mm FLEX DRILL, KNOTLESS HIP FiberTak
ARTHREX, INC.
AR-3600ND-2H
In Commercial Distribution

  • 00888867298026 ()
AR-3600ND-2H

  • Fluted surgical drill bit, reusable
1.8mm DRILL BIT, KNOTLESS HIP FiberTak
ARTHREX, INC.
AR-3600D-2H
In Commercial Distribution

  • 00888867298019 ()
AR-3600D-2H

  • Fluted surgical drill bit, reusable
2-0 SUTURETAPE MENISCUS REPAIR NEEDLES
ARTHREX, INC.
AR-7523
In Commercial Distribution

  • 10888867298009 ()
  • 00888867298002 ()
AR-7523

  • Polyolefin/fluoropolymer suture, multifilament
2-0 SUTURETAPE
ARTHREX, INC.
AR-7521
In Commercial Distribution

  • 00888867297999 ()
  • 10888867297996 ()
AR-7521

  • Polyolefin/fluoropolymer suture, multifilament
SutureTape 1.3mm WH/BL W/ 36.6 RV CT NDL
ARTHREX, INC.
AR-7502-1
In Commercial Distribution

  • 00888867297760 ()
AR-7502-1

  • Polyolefin/fluoropolymer suture, multifilament
Back Grasper with WishBone Handle
ARTHREX, INC.
AR-12531W
In Commercial Distribution

  • 00888867297708 ()
AR-12531W

  • Suturing unit, reusable
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