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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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Bone cutters - 04057176149183

Bone cutter Allport CA 3,1 mm
DFS - DIAMON GmbH
110116
In Commercial Distribution

  • 04057176149176 ()
  • 04057176149183 ()


  • Carbide dental bur, reusable

Bone cutters - 04057176149169

Bone cutter Allport CA 2,7 mm
DFS - DIAMON GmbH
110115
In Commercial Distribution

  • 04057176149152 ()
  • 04057176149169 ()


  • Carbide dental bur, reusable

Bone cutters - 04057176149145

Tissue punch CA 5 mm 1p.
DFS - DIAMON GmbH
111260
In Commercial Distribution

  • 04057176149145 ()


  • Dental soft-tissue coring punch, reusable

Bone cutters - 04057176149138

Tissue punch CA 3,5 mm 1p.
DFS - DIAMON GmbH
111240
In Commercial Distribution

  • 04057176149138 ()


  • Dental soft-tissue coring punch, reusable

Carbide burs - 04057176149022

Ortho carbide bur C219-O CA 1,6
DFS - DIAMON GmbH
110816
In Commercial Distribution

  • 04057176149015 ()
  • 04057176149022 ()


  • Carbide dental bur, reusable

Carbide burs - 04057176148988

Ortho carbide bur C278-O CA 2,3
DFS - DIAMON GmbH
110623
In Commercial Distribution

  • 04057176148971 ()
  • 04057176148988 ()


  • Carbide dental bur, reusable

Bone cutters - 04057176148827

Allport C141 CA L 5,0 mm
DFS - DIAMON GmbH
107950
In Commercial Distribution

  • 04057176148810 ()
  • 04057176148827 ()


  • Carbide dental bur, reusable

Bone cutters - 04057176148803

Allport C141 CA L 4,0 mm
DFS - DIAMON GmbH
107940
In Commercial Distribution

  • 04057176148797 ()
  • 04057176148803 ()


  • Carbide dental bur, reusable

Bone cutters - 04057176148780

Allport C141 CA L 3,5 mm
DFS - DIAMON GmbH
107935
In Commercial Distribution

  • 04057176148773 ()
  • 04057176148780 ()


  • Carbide dental bur, reusable

Bone cutters - 04057176148766

Allport C141 CA L 3,1 mm
DFS - DIAMON GmbH
107931
In Commercial Distribution

  • 04057176148759 ()
  • 04057176148766 ()


  • Carbide dental bur, reusable

Bone cutters - 04057176148742

Allport C141 CA L 2,7 mm
DFS - DIAMON GmbH
107927
In Commercial Distribution

  • 04057176148735 ()
  • 04057176148742 ()


  • Carbide dental bur, reusable

Bone cutters - 04057176148704

Carbide C 152 bone cutter CA
DFS - DIAMON GmbH
110124
In Commercial Distribution

  • 04057176148698 ()
  • 04057176148704 ()


  • Carbide dental bur, reusable

Bone cutters - 04057176148629

Tissue punch CA 4 mm 1p.
DFS - DIAMON GmbH
111250
In Commercial Distribution

  • 04057176148629 ()


  • Dental soft-tissue coring punch, reusable

Polishers - 04057176161451

2metal polisher small point CA 6p
DFS - DIAMON GmbH
800416
In Commercial Distribution

  • 04057176161444 ()
  • 04057176161451 ()


  • Dental polishing brush

Polishers - 04057176161376

2metal polisher small point CA 6pcs
DFS - DIAMON GmbH
800476
In Commercial Distribution

  • 04057176161369 ()
  • 04057176161376 ()


  • Dental polishing brush

800 P37,IG,2L,STD,CA - 00840828191005

800 P37,IG,2L,STD,CA
CURBELL MEDICAL PRODUCTS, INC.
BIC-19F0-E00-8
In Commercial Distribution

  • 00840828191005 ()
28955

  • Electrical mains power extension cable

Diacap® - 04046963178116

DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter

Electrode for ABL analyzers - 05700699456168

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)

NA - 00643169727014

CUSTOM PACK 9E13R 5PK CA ACCESS
MEDTRONIC, INC.
9E13R
Not in Commercial Distribution

  • 20643169727025 ()
  • 00643169727014 ()


  • Cardiopulmonary bypass system blood tubing set

IMMULITE®/IMMULITE® 1000 Systems OV OM-MA (CA 125) - 00630414964331

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

IMMULITE®/IMMULITE® 1000 Systems BRM BR-MA (CA15-3) - 00630414963655

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

IMMULITE® 2000 Systems OV OM-MA (CA125) - 00630414961798

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

IMMULITE® 2000 Systems BRM BR-MA (CA15-3) - 00630414961088

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

IMMULITE®/IMMULITE® 1000 Systems BRM BR-MA Sample Diluent - 00630414953601

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

  • 00630414953601 ()
LBRZ

  • Buffered sample diluent IVD

ADVIA Centaur® CA 15-3® - 00630414461328

CA 15-3 - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10312831
In Commercial Distribution

  • 00630414461328 ()
  • 00630414003481 ()
128535

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CA 15-3® - 00630414461311

CA 15-3 - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10327620
In Commercial Distribution

  • 00630414461311 ()
128534

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CA 125 II - 00630414461304

CA 125 - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10315696
In Commercial Distribution

  • 00630414461304 ()
  • 00630414003504 ()
128533

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CA 125II - 00630414461298

CA 125 - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310443
In Commercial Distribution

  • 00630414461298 ()
128532

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 19-9 - 00630414293516

CA 19-9 Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206239
In Commercial Distribution

  • 00630414293516 ()
11206239

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 15-3 - 00630414293509

CA 15-3 Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206238
In Commercial Distribution

  • 00630414294063 ()
  • 00630414293509 ()
11206238

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 125II - 00630414293493

CA 125II Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206266
In Commercial Distribution

  • 00630414294278 ()
  • 00630414293493 ()
11206266

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 19-9 - 00630414598178

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

Atellica IM CA 19-9 - 00630414598161

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

Atellica IM CA 15-3 - 00630414598130

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

Atellica IM CA 15-3 - 00630414598123

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

Atellica IM CA 125II - 00630414598093

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

Atellica IM CA 125II - 00630414598086

CA 125II Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995481
In Commercial Distribution

  • 00630414598086 ()
10995481

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CA 19-9 DIL - 00630414577135

CA 19-9 bottle - CENTAUR - CONS - 1x25mL
Siemens Healthcare Diagnostics Inc.
10491974
In Commercial Distribution

  • 00630414577135 ()
10491974

  • Buffered sample diluent IVD

ADVIA Centaur® CA 19-9™ - 00630414574257

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

ADVIA Centaur® CA 19-9™ - 00630414574028

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

Maxso MH01 - 00628504370643

MH01, Head, Push Button, CA Burs
Beyes Dental Canada Inc
SL3060
In Commercial Distribution

  • 00628504370643 ()


  • Dental power tool system handpiece, pneumatic

Maxso CH04 - 00628504370551

CH04, Head, Latch Type, CA Burs
Beyes Dental Canada Inc
SL2010
In Commercial Distribution

  • 00628504370551 ()


  • Dental power tool system handpiece, pneumatic

ACE - 00614950010615

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

  • 00614950010615 ()
04962101

  • Fluted surgical drill bit, reusable

ACE - 00614950010608

3.75 COUNTERSINK DRILL CA 24TL TI
ACE SURGICAL SUPPLY CO., INC.
04962001
In Commercial Distribution

  • 00614950010608 ()
04962001

  • Fluted surgical drill bit, reusable

ACE - 00614950010097

* IMPLANT MOUNT DRIVER CA 21TL SS
ACE SURGICAL SUPPLY CO., INC.
04152101
In Commercial Distribution

  • 00614950010097 ()

  • Length: 21 Millimeter
04152101

  • Orthopaedic implant driver

B.BRAUN - 04046964231834

HELP HEPARIN ADSORBER 400 US/CA
B.Braun Avitum AG
7211089
Not in Commercial Distribution

  • 04046964231834 ()
  • 04046964231841 ()
7211089

  • Apheresis kit

Madsen - 05713315009204

1066 MADSEN Astera 2, CA Only
Natus Medical Denmark ApS
8-04-13102-CA
In Commercial Distribution

  • 05713315009204 ()
8-04-13102-CA

  • Speech audiometer

Medline Industries, Inc. - 10889942937783

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

  • 10889942937783 ()
  • 40889942937784 ()
DYNJ35091F

  • General surgical procedure kit, non-medicated, single-use

iCE Surgical Light - 00684706003642

S1 400DT Sgl CA Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003642 ()
C14S51

  • Operating room light

Medline Industries, Inc. - 10889942320707

PROVIDENCE CA D&C/GYN PACK
MEDLINE INDUSTRIES, INC.
DYNJ35091C
In Commercial Distribution

  • 10889942320707 ()
DYNJ35091C

  • General surgical procedure kit, non-medicated, reusable
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