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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3.3 COUNTERSINK DRILL CA 24TL TI
ACE SURGICAL SUPPLY CO., INC.
04962101
In Commercial Distribution

  • 00614950010615 ()
04962101

  • Fluted surgical drill bit, reusable
3.75 COUNTERSINK DRILL CA 24TL TI
ACE SURGICAL SUPPLY CO., INC.
04962001
In Commercial Distribution

  • 00614950010608 ()
04962001

  • Fluted surgical drill bit, reusable
* IMPLANT MOUNT DRIVER CA 21TL SS
ACE SURGICAL SUPPLY CO., INC.
04152101
In Commercial Distribution

  • 00614950010097 ()

  • Length: 21 Millimeter
04152101

  • Orthopaedic implant driver
CA 15-3 Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387018
In Commercial Distribution

  • 00630414953601 ()
LBRZ

  • Buffered sample diluent IVD
CA 19-9 bottle - CENTAUR - CONS - 1x25mL
Siemens Healthcare Diagnostics Inc.
10491974
In Commercial Distribution

  • 00630414577135 ()
10491974

  • Buffered sample diluent IVD
CA 19-9 - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10491379
In Commercial Distribution

  • 00630414574257 ()
10491379

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
CA 19-9 - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10491244
In Commercial Distribution

  • 00630414574028 ()
10491244

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
CA 19-9 - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995490
In Commercial Distribution

  • 00630414598178 ()
10995490

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
CA 19-9 Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995489
In Commercial Distribution

  • 00630414598161 ()
10995489

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
CA 15-3 Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995486
In Commercial Distribution

  • 00630414598130 ()
  • 00630414007397 ()
10995486

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA 15-3 Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995485
In Commercial Distribution

  • 00630414598123 ()
10995485

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA 125II Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995482
In Commercial Distribution

  • 00630414598093 ()
  • 00630414007380 ()
10995482

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
CA 125II Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995481
In Commercial Distribution

  • 00630414598086 ()
10995481

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
CA 125 - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380969
In Commercial Distribution

  • 00630414964331 ()
LKOP1

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
CA 15-3 - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380948
In Commercial Distribution

  • 00630414963655 ()
LKBR1

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA 125 - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380972
In Commercial Distribution

  • 00630414961798 ()
L2KOP2

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
CA 15-3 - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380983
In Commercial Distribution

  • 00630414961088 ()
L2KBR2

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
PROVIDENCE CA D&C/GYN PACK
MEDLINE INDUSTRIES, INC.
DYNJ35091C
In Commercial Distribution

  • 10889942320707 ()
DYNJ35091C

  • General surgical procedure kit, non-medicated, reusable
CUSTOM PACK 9E13R 5PK CA ACCESS
MEDTRONIC, INC.
9E13R
Not in Commercial Distribution

  • 20643169727025 ()
  • 00643169727014 ()


  • Cardiopulmonary bypass system blood tubing set
1066 MADSEN Astera 2, CA Only
Natus Medical Denmark ApS
8-04-13102-CA
In Commercial Distribution

  • 05713315009204 ()
8-04-13102-CA

  • Speech audiometer
PROVIDENCE CA D&C/GYN PACK
MEDLINE INDUSTRIES, INC.
DYNJ35091F
In Commercial Distribution

  • 10889942937783 ()
  • 40889942937784 ()
DYNJ35091F

  • General surgical procedure kit, non-medicated, single-use
PLAIN CARDBD SPLINT 24", CA 50
MORRISON MEDICAL, LTD
1520-50
In Commercial Distribution

  • 00647921152052 ()
  • 00647921152069 ()
1520-50

  • First aid limb splint, non-mouldable, single-use
E733 Ca electrode for ABL7XX/8XX
Radiometer Medical ApS
945-616
In Commercial Distribution

  • 05700699456168 ()
945-616

  • Calcium (Ca2+) IVD, kit, ion-selective electrode (ISE)
S1 400DT Sgl CA Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003642 ()
C14S51

  • Operating room light
MH01,Head, Push Button, CA Burs
Beyes Dental Canada Inc
SL3060
In Commercial Distribution

  • 00990010301924 ()
MH01

  • Dental power tool handpiece motorless component
CH04,Head, Latch Type, CA Burs
Beyes Dental Canada Inc
SL2010
In Commercial Distribution

  • 00990010301832 ()
CH04

  • Dental power tool handpiece motorless component
CH02,Head, Push Botton, CA Burs
Beyes Dental Canada Inc
SL2008
In Commercial Distribution

  • 00990010301825 ()
CH02

  • Dental power tool handpiece motorless component
CA (Calcium) 4 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST251
In Commercial Distribution

  • 00817302020403 ()

  • Kit contains 1 R1 bottle and 1 package insert
  • Total Volume: 57 Milliliter
ST251

  • Calcium (Ca2+) IVD, kit, spectrophotometry
DURA-STICK BG 2" SQ 40/CA
DJO, LLC
42176
In Commercial Distribution

  • 00888912340793 ()


  • Transcutaneous electrical stimulation electrode, single-use
MASK,OXY,ADL,SWIVEL 50/CA
TRI-ANIM HEALTH SERVICES, INC.
301-180SWVL-MO
In Commercial Distribution

  • 00818834022026 ()
  • 00818834020947 ()
301-180SWVL-MO

  • Rebreathing oxygen face mask
CANNULA,ADL,SOFT,25'*,25/CA
TRI-ANIM HEALTH SERVICES, INC.
301-115
In Commercial Distribution

  • 00818834021852 ()
  • 00818834020770 ()
301-115

  • Nasal oxygen cannula, basic
CANNULA,ADL,SOFT,14'*,50/CA
TRI-ANIM HEALTH SERVICES, INC.
301-114
In Commercial Distribution

  • 00818834021845 ()
  • 00818834020763 ()
301-114

  • Nasal oxygen cannula, basic
FULL SET INCLUDING TRYPTIK CA INSTRUMENTS
SpineArt SA
MOS-BX 10 00-N
In Commercial Distribution

  • 07640139340719 ()
MOS-BX 10 00-N

  • Instrument tray, reusable
UNIVERS CA HUMERAL HEAD INSTRUMENT CASE
ARTHREX, INC.
AR-9200CAC
In Commercial Distribution

  • 00888867137073 ()
AR-9200CAC

  • Device sterilization/disinfection container, reusable
UNIVERS CA HUMERAL HEAD, 48/19
ARTHREX, INC.
AR-9148-19CA
In Commercial Distribution

  • 00888867136168 ()
  • M150AR914819CA1 ()
AR-9148-19CA

  • Uncoated shoulder humeral stem prosthesis
UNIVERS CA HUMERAL HEAD, 46/20
ARTHREX, INC.
AR-9146-20CA
In Commercial Distribution

  • 00888867136083 ()
  • M150AR914620CA1 ()
AR-9146-20CA

  • Uncoated shoulder humeral stem prosthesis
UNIVERS CA HUMERAL HEAD, 46/18
ARTHREX, INC.
AR-9146-18CA
In Commercial Distribution

  • 00888867136052 ()
  • M150AR914618CA1 ()
AR-9146-18CA

  • Uncoated shoulder humeral stem prosthesis
UNIVERS CA HUMERAL HEAD, 44/19
ARTHREX, INC.
AR-9144-19CA
In Commercial Distribution

  • 00888867135611 ()
  • M150AR914419CA1 ()
AR-9144-19CA

  • Uncoated shoulder humeral stem prosthesis
UNIVERS CA HUMERAL HEAD, 44/17
ARTHREX, INC.
AR-9144-17CA
In Commercial Distribution

  • 00888867135581 ()
  • M150AR914417CA1 ()
AR-9144-17CA

  • Uncoated shoulder humeral stem prosthesis
UNIVERS CA HUMERAL HEAD, 42/17
ARTHREX, INC.
AR-9142-17CA
In Commercial Distribution

  • 00888867135505 ()
  • M150AR914217CA1 ()
AR-9142-17CA

  • Uncoated shoulder humeral stem prosthesis
Revers Trial CA Head, 56/22
ARTHREX, INC.
AR-9556-22RCAT
In Commercial Distribution

  • 00888867229761 ()
  • M150AR955622RCAT0 ()
AR-9556-22RCAT

  • Reverse shoulder head prosthesis trial
Revers Trial CA Head, 54/23
ARTHREX, INC.
AR-9554-23RCAT
Not in Commercial Distribution

  • 00888867229754 ()
  • M150AR955423RCAT0 ()
AR-9554-23RCAT

  • Reverse shoulder head prosthesis trial
Revers Trial CA Head, 54/21
ARTHREX, INC.
AR-9554-21RCAT
Not in Commercial Distribution

  • 00888867229747 ()
  • M150AR955421RCAT0 ()
AR-9554-21RCAT

  • Reverse shoulder head prosthesis trial
Revers Trial CA Head, 52/22
ARTHREX, INC.
AR-9552-22RCAT
Not in Commercial Distribution

  • 00888867229730 ()
  • M150AR955222RCAT0 ()
AR-9552-22RCAT

  • Reverse shoulder head prosthesis trial
Revers Trial CA Head, 52/20
ARTHREX, INC.
AR-9552-20RCAT
Not in Commercial Distribution

  • 00888867229723 ()
  • M150AR955220RCAT0 ()
AR-9552-20RCAT

  • Reverse shoulder head prosthesis trial
Revers Trial CA Head, 48/19
ARTHREX, INC.
AR-9548-19RCAT
Not in Commercial Distribution

  • 00888867229686 ()
  • M150AR954819RCAT0 ()
AR-9548-19RCAT

  • Reverse shoulder head prosthesis trial
Revers Trial CA Head, 46/18
ARTHREX, INC.
AR-9546-18RCAT
Not in Commercial Distribution

  • 00888867229662 ()
  • M150AR954618RCAT0 ()
AR-9546-18RCAT

  • Reverse shoulder head prosthesis trial
Revers Trial CA Head, 44/19
ARTHREX, INC.
AR-9544-19RCAT
Not in Commercial Distribution

  • 00888867229655 ()
  • M150AR954419RCAT0 ()
AR-9544-19RCAT

  • Reverse shoulder head prosthesis trial
Revers Trial CA Head, 44/17
ARTHREX, INC.
AR-9544-17RCAT
In Commercial Distribution

  • 00888867229648 ()
  • M150AR954417RCAT0 ()
AR-9544-17RCAT

  • Reverse shoulder head prosthesis trial
Revers CA Humeral Head, 56/22
ARTHREX, INC.
AR-9556-22RCA
In Commercial Distribution

  • 00888867229594 ()
  • M150AR955622RCA1 ()
AR-9556-22RCA

  • Total reverse shoulder prosthesis
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