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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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Anti-D Series 5 (Murine Monoclonal) - 10888234002017

Anti-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.
IMMUCOR, INC.
0006415
In Commercial Distribution

  • 10888234002017 ()
0006415

  • Anti-Rh(D) red blood cell grouping IVD, antibody

Anti-D (Monoclonal Blend) Series 5 - 10888234000563

Anti-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.
IMMUCOR, INC.
0006414
In Commercial Distribution

  • 10888234000563 ()
0006414

  • Anti-Rh(D) red blood cell grouping IVD, antibody

HiRes lens for BIOM 5 - 04049584007766

HiRes lens for BIOM 5
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
53606
In Commercial Distribution

  • 04049584007766 ()


  • Ophthalmic surgical microscope

90D lens for BIOM 5 - 04049584007759

90D lens for BIOM 5
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
53604
In Commercial Distribution

  • 04049584007759 ()


  • Ophthalmic surgical microscope

WFE lens for BIOM 5 - 04049584007735

WFE lens for BIOM 5
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
53602
In Commercial Distribution

  • 04049584007735 ()


  • Ophthalmic surgical microscope

Universal Trial Frame UB 5 - 04049584005816

Universal Trial Frame UB 5
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
42550
In Commercial Distribution

  • 04049584005816 ()


  • Trial lens frame

ERA® Standard 5° Female - 00841549102189

ERA® Standard 5° Female. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
811601
In Commercial Distribution

  • 00841549102189 ()


  • Resilient dental precision attachment

Radial Osteotome, 14mm X 5” - 00847538008791

Radial Osteotome, 14mm X 5”
SYMMETRY MEDICAL INC.
11-034-500
In Commercial Distribution

  • 00847538008791 ()
2709-04-014;47-9986-020-30

  • Orthopaedic osteotome

Radial Osteotome, 10mm X 5 - 00847538008784

Radial Osteotome 10 X 5
SYMMETRY MEDICAL INC.
11-033-500
In Commercial Distribution

  • 00847538008784 ()
2709-04-012;47-9986-020-28

  • Orthopaedic osteotome

Radial Osteotome, 12mm X 5” - 00847538008678

Radial Osteotome, 12mm X 5”
SYMMETRY MEDICAL INC.
11-020-500
In Commercial Distribution

  • 00847538008678 ()
2709-04-013;47-9986-020-29

  • Orthopaedic osteotome

Radial Osteotome, 12mm X 5” - 00847538001761

Radial Osteotome, 12mm X 5”
SYMMETRY MEDICAL INC.
11-020-000
In Commercial Distribution

  • 00847538001761 ()


  • Orthopaedic osteotome

Mouse anti-Cytokeratin 5&6 Concentrate - 10190302007993

No Description
LIFE TECHNOLOGIES CORPORATION
180267
Not in Commercial Distribution

  • 10190302007993 ()


  • Multiple solid tumour differentiation marker IVD, kit, enzyme immunoassay (EIA)

MST Replacement O-rings 5 sets - 00844685002696

No Description
MICROSURGICAL TECHNOLOGY, INC.
IH-90330
In Commercial Distribution

  • 00844685002696 ()
IH-90330

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MST Replacement O-rings 5 sets - 00844685002689

No Description
MICROSURGICAL TECHNOLOGY, INC.
TA-93331
In Commercial Distribution

  • 00844685002689 ()
TA-93331

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

VIAL ADAPTER, PLASTIC, 5 PACK - 00850010197272

No Description
QUINTRON INSTRUMENT COMPANY, INC.
QT02688
In Commercial Distribution

  • 00850010197876 ()
  • 00850010197272 ()
QT02688

  • Gas chromatography analyser IVD

ihcDirect® Cytokeratin 5 Ab - 00850000596139

Clone R226
NOVODIAX, INC.
K32014-015
Not in Commercial Distribution

  • 00850000596139 ()

  • Total Volume: 15 Milliliter
K32014-015

  • Cytokeratin IVD, kit, enzyme immunohistochemistry

ihcDirect® Cytokeratin 5 Ab-Blk - 00850000596122

Clone R226
NOVODIAX, INC.
K47014-015
Not in Commercial Distribution

  • 00850000596122 ()

  • Total Volume: 15 Milliliter
K47014-015

  • Cytokeratin IVD, kit, enzyme immunohistochemistry

ihcDirect® Cytokeratin 5 Ab-Blk - 00850000596115

Clone R226
NOVODIAX, INC.
K47014-010
Not in Commercial Distribution

  • 00850000596115 ()

  • Total Volume: 10 Milliliter
K47014-010

  • Cytokeratin IVD, kit, enzyme immunohistochemistry

ihcDirect® Cytokeratin 5 Ab-Blk - 00850000596108

Clone R226
NOVODIAX, INC.
K47014-005
Not in Commercial Distribution

  • 00850000596108 ()

  • Total Volume: 5 Milliliter
K47014-005

  • Cytokeratin IVD, kit, enzyme immunohistochemistry

CA 1:5 L Micro-Series - J00716006900011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600690-001
In Commercial Distribution

  • J00716006900011 ()
1600690-001

  • Dental power tool system handpiece, remotely-driven

PEESO REAMERS RA, N°5 - J01020442

Rack of 6 - 32 mm length - Diam 1.50 Peeso Reamers are mechanized dental instruments used for accessing to the root canal and enlarging the opening of the coronal part of the root canal, before and after using files. Peeso Reamers are also used for pin or post hole preparation.
Produits dentaires S.A.
20442
In Commercial Distribution

  • J01020442 ()


  • Endodontic enlarger, reusable

GATES-GLIDDEN DRILLS RA, N°5 - J01020342

Rack of 6 - 32 mm length - Diam 1.30 Gates Glidden are mechanized dental instruments used for accessing to the root canal and enlarging the opening of the coronal part of the root canal, before and after using files. Gates-Glidden are also used for pin or post hole preparation.
Produits dentaires S.A.
20342
In Commercial Distribution

  • J01020342 ()


  • Endodontic enlarger, reusable

CA 1:5 L Lares - J00716010580011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601058-001
In Commercial Distribution

  • J00716010580011 ()
1601058-001

  • Pneumatic dental handpiece coupler

Mirror, round, 5 mm, polished - 04250676719591

very fine, shaft length 125 mm for use with handle 90-220-00
Spiggle & Theis Medizintechnik GmbH
90-222-05
In Commercial Distribution

  • 04250676719591 ()
90-222-05

  • General/plastic surgery mirror

5 Pin Bolt Wrench small - 04251269200755

No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269200755 ()
112996

  • MRI system coil, radio-frequency

ADVIA Centaur® Multi-Diluent 5 - 00630414175263

Multidil 5Readypack (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309946
Not in Commercial Distribution

  • 00630414175263 ()
  • 00630414003122 ()
110317

  • Buffered sample diluent IVD

ALLEVYN THIN 10X10CM CTN 5 - 05000223452919

Self-Adhesive Polyurethane Dressing
SMITH & NEPHEW MEDICAL LIMITED
66047578
In Commercial Distribution

  • 05000223452926 ()
  • 05000223452919 ()
  • 05000223452933 ()
66047578

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

ACTICOAT 7 4" X 5" - 05000223449919

7 day silver-coated antimicrobial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
20141
In Commercial Distribution

  • 00040565121376 ()
  • 05000223449919 ()
  • 30040565121377 ()
20141

  • Wound-nonadherent dressing, absorbent, antimicrobial

I-GEL SUPRAGLOTTIC AIRWAY, SIZE 5 - 05030267073702

I-GEL SUPRAGLOTTIC AIRWAY, SIZE 5
Intersurgical Incorporated
8205000
In Commercial Distribution

  • 05030267047079 ()
  • 05030267073702 ()


  • Laryngeal mask airway, single-use

Cytokeratin 5/6 (CK5/6) - 00847627029751

No Description
BIOCARE MEDICAL LLC
ALI105G7
In Commercial Distribution

  • 00847627029751 ()


  • Cytokeratin IVD, antibody

Nebula Stem, Broach, Size 5 - 09348215134822

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-591-005
In Commercial Distribution

  • 09348215134822 ()


  • Orthopaedic broach

Nebula High Offset Size 5 - 09348215134693

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-59-0105
In Commercial Distribution

  • 09348215134693 ()


  • Coated hip femur prosthesis, modular

Nebula Standard Offset Size 5 - 09348215134563

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-59-0005
In Commercial Distribution

  • 09348215134563 ()


  • Coated hip femur prosthesis, modular

Baha® Fitting Software 5 - 09321502044097

N/A
Cochlear Bone Anchored Solutions AB
P1457850
In Commercial Distribution

  • 09321502044097 ()
P1457850

  • Hearing aid wireless-fitting computer-aided set

Baha 5 Power Inner case - 09321502034661

No Description
Cochlear Bone Anchored Solutions AB
95980
In Commercial Distribution

  • 09321502034661 ()
95980

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 SuperPower Actuator unit - 09321502034012

No Description
Cochlear Bone Anchored Solutions AB
95464
In Commercial Distribution

  • 09321502034012 ()
95464

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 SuperPower Actuator unit - 09321502034005

No Description
Cochlear Bone Anchored Solutions AB
95463
In Commercial Distribution

  • 09321502034005 ()
95463

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 SuperPower Actuator unit - 09321502033992

No Description
Cochlear Bone Anchored Solutions AB
95462
In Commercial Distribution

  • 09321502033992 ()
95462

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 SuperPower Actuator Unit - 09321502033985

No Description
Cochlear Bone Anchored Solutions AB
95461
In Commercial Distribution

  • 09321502033985 ()
95461

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 SuperPower Bodyworn cable - 09321502033961

No Description
Cochlear Bone Anchored Solutions AB
95939
In Commercial Distribution

  • 09321502033961 ()

  • 50 cm cable
  • Length: 50 Centimeter
95939

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 SuperPower Bodyworn cable - 09321502033954

No Description
Cochlear Bone Anchored Solutions AB
95938
In Commercial Distribution

  • 09321502033954 ()

  • Length: 50 Centimeter
  • 50 cm cable
95938

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 SuperPower Bodyworn cable - 09321502033947

No Description
Cochlear Bone Anchored Solutions AB
95937
In Commercial Distribution

  • 09321502033947 ()

  • Length: 50 Centimeter
  • 50 cm cable
95937

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 SuperPower Bodyworn cable - 09321502033930

No Description
Cochlear Bone Anchored Solutions AB
95936
In Commercial Distribution

  • 09321502033930 ()

  • Length: 50 Centimeter
  • 50 cm cable
95936

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 SuperPower Processing unit - 09321502033831

No Description
Cochlear Bone Anchored Solutions AB
96004
In Commercial Distribution

  • 09321502033831 ()
96004

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 SuperPower Processing unit - 09321502033824

No Description
Cochlear Bone Anchored Solutions AB
96003
In Commercial Distribution

  • 09321502033824 ()
96003

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 SuperPower Processing unit - 09321502033800

No Description
Cochlear Bone Anchored Solutions AB
96001
In Commercial Distribution

  • 09321502033800 ()
96001

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 Sound Processor, Blonde - 09321502028783

No Description
Cochlear Bone Anchored Solutions AB
95201
In Commercial Distribution

  • 09321502028783 ()
95201

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 Sound Processor, Black - 09321502028776

No Description
Cochlear Bone Anchored Solutions AB
95202
In Commercial Distribution

  • 09321502028776 ()
95202

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 Sound Processor, Silver - 09321502028769

No Description
Cochlear Bone Anchored Solutions AB
95203
In Commercial Distribution

  • 09321502028769 ()
95203

  • Bone-conduction hearing implant system sound processor/vibrator

Baha 5 Sound Processor, Brown - 09321502028752

No Description
Cochlear Bone Anchored Solutions AB
95204
In Commercial Distribution

  • 09321502028752 ()
95204

  • Bone-conduction hearing implant system sound processor/vibrator
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