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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No Description
Provision
AR-1250LTSR
In Commercial Distribution

  • 00810041639660 ()


  • Drilling power tool attachment, basic
No Description
Provision
AR-8911DC
In Commercial Distribution

  • 00810041639547 ()


  • Drilling power tool attachment, basic
No Description
Provision
AR-3671DS
In Commercial Distribution

  • 00810041639394 ()


  • Drilling power tool attachment, basic
No Description
Provision
AR-6527-05
In Commercial Distribution

  • 00810041638786 ()


  • Surgical saw blade, reciprocating, reprocessed
No Description
Provision
AR-1941D
In Commercial Distribution

  • 00810041638779 ()


  • Drilling power tool attachment, basic
No Description
Provision
AR-1912
In Commercial Distribution

  • 00810041638762 ()


  • Drilling power tool attachment, basic
No Description
Provision
AR-4160-24
In Commercial Distribution

  • 00810041638106 ()


  • Drilling power tool attachment, basic
No Description
Clarius Mobile Health Corp
Battery - ARTHREX
In Commercial Distribution

  • 07540205000335 ()
80-02-00001; AR-3500-01B

  • Portable/mobile rechargeable battery pack
No Description
Clarius Mobile Health Corp
L7 Premium Non-Commercial ARTHREX
In Commercial Distribution

  • 07540205000120 ()
  • 07540205000311 ()
80-02-00014; 50-02-00006

  • Hand-held ultrasound imaging system, body-surface
No Description
Clarius Mobile Health Corp
C3-45 Premium Non-Commercial ARTHREX
In Commercial Distribution

  • 07540205000090 ()
  • 07540205000298 ()
80-02-00012; 50-02-00003

  • Hand-held ultrasound imaging system, body-surface
ARTHREX Synergy Curvilinear Scanner
Clarius Mobile Health Corp
C3-45 Premium
In Commercial Distribution

  • 07540205000090 ()
  • 07540205000199 ()
80-02-00009; 50-02-00003

  • Hand-held ultrasound imaging system, body-surface
ARTHREX Charger
Clarius Mobile Health Corp
Charger
In Commercial Distribution

  • 07540205000175 ()
80-02-00002; AR-3500-01C

  • Noninvasive device battery charger
ARTHREX Curvilinear Scanner
Clarius Mobile Health Corp
C3-45
In Commercial Distribution

  • 07540205000090 ()
  • 07540205000038 ()
80-02-00003; 50-02-00003; AR-3501B-C3

  • Hand-held ultrasound imaging system, body-surface
ARTHREX Linear Transducer
Clarius Mobile Health Corp
L7
In Commercial Distribution

  • 07540205000120 ()
  • 07540205000021 ()
80-02-00006; 50-02-00006; AR-3501B-L7

  • Hand-held ultrasound imaging system, body-surface
Matrix Strip
COLLAGEN MATRIX, INC.
ABS-3500-40
In Commercial Distribution

  • 00813954026558 ()

  • 40cc, 25.0cm x 2.0cm x 0.8cm
ABS-3500-40

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Strip
COLLAGEN MATRIX, INC.
ABS-3500-20
In Commercial Distribution

  • 00813954026541 ()

  • 20cc, 12.5cm x 2.0cm x 0.8cm
ABS-3500-20

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Strip
COLLAGEN MATRIX, INC.
ABS-3500-10
In Commercial Distribution

  • 00813954026534 ()

  • 10cc, 6.25cm x 2.0cm x 0.8cm
ABS-3500-10

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Strip
COLLAGEN MATRIX, INC.
ABS-3500-05
In Commercial Distribution

  • 00813954026527 ()

  • 5cc, 3.2cm x 2.0cm x 0.8cm
ABS-3500-05

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Putty
COLLAGEN MATRIX, INC.
ABS-3400-20
In Commercial Distribution

  • 00813954025940 ()

  • 20cc, 5.0cc x 5.0cc x 0.8cc
ABS-3400-20

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Putty
COLLAGEN MATRIX, INC.
ABS-3400-10
In Commercial Distribution

  • 00813954025933 ()

  • 10cc, 3.5cm x 3.5cm x 0.8cm
ABS-3400-10

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Putty
COLLAGEN MATRIX, INC.
ABS-3400-05
In Commercial Distribution

  • 00813954025926 ()

  • 5cc, 2.5cm x 2.5cm x 0.8cm
ABS-3400-05

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Putty
COLLAGEN MATRIX, INC.
ABS-3400-02
In Commercial Distribution

  • 00813954025919 ()

  • 2.5cc, 2.0cm x 2.0cm x 0.8cm
ABS-3400-02

  • Bone matrix implant, animal-derived, bioabsorbable
Collagen Tendon Wrap
COLLAGEN MATRIX, INC.
ABS-16025
In Commercial Distribution

  • 00813954025735 ()

  • 16.0 mm ID x 2.5 cm length
ABS-16025

  • Nerve guide, animal-derived
Collagen Tendon Wrap
COLLAGEN MATRIX, INC.
ABS-16050
In Commercial Distribution

  • 00813954025728 ()

  • 16.0 mm ID x 5.0 cm length
ABS-16050

  • Nerve guide, animal-derived
Matrix Strip
COLLAGEN MATRIX, INC.
ABS-3500-40
In Commercial Distribution

  • 00813954025582 ()

  • 40cc, 25.0cm x 2.0cm x 0.8cm
ABS-3500-40

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Strip
COLLAGEN MATRIX, INC.
ABS-3500-20
In Commercial Distribution

  • 00813954025575 ()

  • 20cc, 12.5cm x 2.0cm x 0.8cm
ABS-3500-20

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Strip
COLLAGEN MATRIX, INC.
ABS-3500-10
In Commercial Distribution

  • 00813954025568 ()

  • 10cc, 6.25cm x 2.0cm x 0.8cm
ABS-3500-10

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Strip
COLLAGEN MATRIX, INC.
ABS-3500-05
In Commercial Distribution

  • 00813954025551 ()

  • 5cc, 3.2cm x 2.0cm x 0.8cm
ABS-3500-05

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Putty
COLLAGEN MATRIX, INC.
ABS-3400-10
In Commercial Distribution

  • 00813954025421 ()

  • 10cc, 3.5cm x 3.5cm x 0.8cm
ABS-3400-10

  • Bone matrix implant, animal-derived, bioabsorbable
Matrix Putty
COLLAGEN MATRIX, INC.
ABS-3400-20
In Commercial Distribution

  • 00813954025414 ()

  • 20cc, 5.0cc x 5.0cc x 0.8cc
ABS-3400-20

  • Bone matrix implant, animal-derived, bioabsorbable
DISSECTOR, CURVED, HL 4.2MM X 19CM
ARTHREX, INC.
AR-6420CDS
In Commercial Distribution

  • 10888867039190 ()
  • 00888867039193 ()
AR-6420CDS

  • Arthroscopic shaver system, electrically-powered
CURVED BONE CUTTER, 4.20MM X 19CM
ARTHREX, INC.
AR-6420CBC
In Commercial Distribution

  • 10888867039183 ()
  • 00888867039186 ()
AR-6420CBC

  • Arthroscopic shaver system, electrically-powered
BONE CUTR,HL 4.2MMX 19CM
ARTHREX, INC.
AR-6420BC
In Commercial Distribution

  • 10888867039169 ()
  • 00888867039162 ()
AR-6420BC

  • Arthroscopic shaver system, electrically-powered
BURR, ROUND, HL, 8 FLUTE, 4.0MM X 19CM
ARTHREX, INC.
AR-6400RBE
In Commercial Distribution

  • 10888867039121 ()
  • 00888867039124 ()
AR-6400RBE

  • Arthroscopic shaver system, electrically-powered
Y-INFLOW TUBING, 7.0MM
ARTHREX, INC.
AR-6200
In Commercial Distribution

  • 10888867039008 ()
  • 00888867039001 ()
AR-6200

  • Cardiac ablation system irrigation tubing set
iBALANCE, HANDLE, QUICK CONNECT
ARTHREX, INC.
AR-613-8
In Commercial Distribution

  • 00888867038998 ()
AR-613-8

  • Orthopaedic inorganic implant inserter/extractor, reusable
CRESCENT, QUICKPASS LASSO
ARTHREX, INC.
AR-6068C
In Commercial Distribution

  • 00888867038981 ()
AR-6068C

  • Suturing unit, single-use
90 DEG TIGHT CURVE QUICKPASS LASSO
ARTHREX, INC.
AR-6068-90T
In Commercial Distribution

  • 00888867038974 ()
AR-6068-90T

  • Suturing unit, single-use
90 DEG CURVE RIGHT, QUICKPASS LASSO
ARTHREX, INC.
AR-6068-90R
In Commercial Distribution

  • 00888867038967 ()
AR-6068-90R

  • Suturing unit, single-use
90 DEG CURVE LEFT, QUICKPASS LASSO
ARTHREX, INC.
AR-6068-90L
In Commercial Distribution

  • 00888867038950 ()
AR-6068-90L

  • Suturing unit, single-use
90 DEG CURVE STRAIGHT, QUICKPASS LASSO
ARTHREX, INC.
AR-6068-90
In Commercial Distribution

  • 00888867038943 ()
AR-6068-90

  • Suturing unit, single-use
45 DEG CURVE RIGHT, FASTPASS LASSO
ARTHREX, INC.
AR-6068-45R
In Commercial Distribution

  • 00888867038936 ()
AR-6068-45R

  • Suturing unit, single-use
45 DEG CURVE LEFT, QUICKPASS LASSO
ARTHREX, INC.
AR-6068-45L
In Commercial Distribution

  • 00888867038929 ()
AR-6068-45L

  • Suturing unit, single-use
30 DEG STRAIGHT QUICKPASS LASSO
ARTHREX, INC.
AR-6068-30
In Commercial Distribution

  • 00888867038912 ()
AR-6068-30

  • Suturing unit, single-use
25 DEG TIGHT CURVE RIGHT QUICKPASS LASSO
ARTHREX, INC.
AR-6068-25TR
In Commercial Distribution

  • 00888867038905 ()
AR-6068-25TR

  • Suturing unit, single-use
25 DEG TIGHT CURVE LEFT, QUICKPASS LASSO
ARTHREX, INC.
AR-6068-25TL
In Commercial Distribution

  • 00888867038899 ()
AR-6068-25TL

  • Suturing unit, single-use
QUICKPASS LASSO WIRE
ARTHREX, INC.
AR-6068-01
In Commercial Distribution

  • 10888867038889 ()
  • 00888867038882 ()
AR-6068-01

  • Suturing unit, single-use
iBALANCE TKA, LMR INSTRUMENT CASE
ARTHREX, INC.
AR-605-C
In Commercial Distribution

  • 00888867038875 ()
AR-605-C

  • Device sterilization/disinfection container, reusable
iBALANCE TKA, LMR TIB STYLUS
ARTHREX, INC.
AR-605-9
In Commercial Distribution

  • 00888867038868 ()
AR-605-9

  • Orthopaedic prosthesis implantation positioning instrument, reusable
iBALANCE, T20 DRIVER
ARTHREX, INC.
AR-605-8
In Commercial Distribution

  • 00888867038851 ()
AR-605-8

  • Orthopaedic implant driver
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