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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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CALIPER CLC 40 CWM, 17cm CONTACT FRONT NEW
Power Dental U.S.A. Inc.
N4613RAN
In Commercial Distribution

  • D943N4613RAN00 ()
N4613RAN

  • General-purpose calliper, metallic
POWER TWIST PERIOTOME 4mm ANTERIOR, STR-R TITANIUM NEW
Power Dental U.S.A. Inc.
N3895GN
In Commercial Distribution

  • D943N3895GN00 ()
N3895GN

  • Periotome, reusable
POWER TWIST PERIOTOME 4mm ANTERIOR, STR-L TITANIUM NEW
Power Dental U.S.A. Inc.
N3894GN
In Commercial Distribution

  • D943N3894GN00 ()
N3894GN

  • Periotome, reusable
OC-Auto Sampling Bottles, 1000 bottles New Brunswick/Quebec
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCS2-NBQ
In Commercial Distribution

  • 00855574005575 ()


  • Faecal occult blood IVD, reagent
PREP AREA FOR A NEW OR REPLACEMENT IV
STRADIS MEDICAL LLC
570-2831
In Commercial Distribution

  • M57257028311 ()


  • Peripherally-inserted central venous catheter
AUX. BASE CONNECTOR KIT 3100/A & NEW N'S
SKYTRON LLC
D5-060-24
In Commercial Distribution

  • 10841736113827 ()


  • Universal operating table, electromechanical
5 1/2 inch New Orleans Eye Loop
Surgical Direct, Inc.
SD93445013
In Commercial Distribution

  • B382SD934450130 ()
SD93445013

  • Bone curette, reusable
Abutment New Non Engaging H 3.0 JDEvolution S
J DENTAL CARE SRL
Abutment New Non Engaging H 3.0 JDEvolution S
In Commercial Distribution

  • 08055510179687 ()
ESTIB30NENC

  • Dental implant system
Abutment New Non Engaging H 3.0 JDEvolution Plus
J DENTAL CARE SRL
Abutment New Non Engaging H 3.0 JDEvolution Plus
In Commercial Distribution

  • 08055510179472 ()
EVTIB30NENC:

  • Dental implant system
Surgical tray with new drill stops JDEvolution Plus
J DENTAL CARE SRL
Surgical tray with new drill stops JDEvolution Plus
In Commercial Distribution

  • 08055510173432 ()
EVSTRAYRN:

  • Dental implant system
Arch Kit New Pink (5,5 mm. / 7,5 mm.)
BIOLOREN SRL
TAKITNWPP
In Commercial Distribution

  • 08056099232442 ()
  • 18056099232449 ()


  • Dental implant suprastructure, permanent, preformed
Abutment New Engaging for Angulated Channel JDEvolution Plus
J DENTAL CARE SRL
Abutment New Engaging for Angulated Channel JDEvolution Plus
In Commercial Distribution

  • 08056591022138 ()
EVA150C:

  • Dental implant system
Abutment New Non Engaging H 3.0 JDIcon Plus
J DENTAL CARE SRL
Abutment New Non Engaging H 3.0 JDIcon Plus
In Commercial Distribution

  • 08056591010357 ()
ICTIB30NENC.

  • Dental implant system
Abutment New Non Engaging H 1.5 JDIcon Plus
J DENTAL CARE SRL
Abutment New Non Engaging H 1.5 JDIcon Plus
In Commercial Distribution

  • 08056591010333 ()
ICTIB15NENC.

  • Dental implant system
Abutment New Non Engaging H 4.0 JDIcon Plus
J DENTAL CARE SRL
Abutment New Non Engaging H 4.0 JDIcon Plus
In Commercial Distribution

  • 08056591012450 ()
ICTIB40NENC.

  • Dental implant system
Implant Replica CAD CAM New JDIcon Ultra S
J DENTAL CARE SRL
Implant Replica CAD CAM New JDIcon Ultra S
In Commercial Distribution

  • 08056591012368 ()
ISANCN

  • Dental implant system
CENSITRAC READY NEW ORLEANS NH SERR 7" TC
SKLAR CORPORATION
21-8082C
In Commercial Distribution

  • 10649111393594 ()


  • Suturing needle holder, reusable
Personal Use Kit OC-Auto, for New York, NY
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 916099
In Commercial Distribution

  • 00816917022550 ()


  • Faecal occult blood IVD, reagent
OC-Auto Sampling Bottles, 200 bottles New Brunswick/Quebec
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCS1-NBQ
In Commercial Distribution

  • 00816917024967 ()


  • Faecal occult blood IVD, reagent
TQMPL Face Mask - ASTM 1 - Green / Turquoise - New
TOP QUALITY MANUFACTURING, INC.
FM2-1804
In Commercial Distribution

  • TQ26FM2180410 ()
  • TQ26FM2180411 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
TQMPL Face Mask - ASTM 1 - Purple / Lavender - New
TOP QUALITY MANUFACTURING, INC.
FM2-1803
In Commercial Distribution

  • TQ26FM2180310 ()
  • TQ26FM2180311 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
PLIERS, OPERATIVE MICRO-TISSUE-FORCEPS, NEW DESIGN HÜRZELER / ZUHR, 17,5CM,
Helmut Zepf Medizintechnik GmbH
22.810.17HZU
In Commercial Distribution

  • EZPF2281017HZU0 ()
22.810.17HZU

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
New LIF Implant Slide, No Stop, 26 MM
ALPHATEC SPINE, INC.
CI-11291-300-26-1
In Commercial Distribution

  • 00840180517123 ()


  • Orthopaedic graft guide
New LIF Implant Slide, No Stop, 22 MM
ALPHATEC SPINE, INC.
CI-11291-300-22-1
In Commercial Distribution

  • 00840180517116 ()


  • Orthopaedic graft guide
Vertebral Body Punch, 20 MM, Stop, New Handle
ALPHATEC SPINE, INC.
CI-11267-15
In Commercial Distribution

  • 00840180516591 ()


  • Spinal rongeur
Vertebral Body Punch, 10 MM, Stop, New Handle
ALPHATEC SPINE, INC.
CI-11267-10
In Commercial Distribution

  • 00840180516584 ()


  • Spinal rongeur
Patient Lift,New Style,Silver Vein,1/cs
Drive Devilbiss Healthcare
13023SV
In Commercial Distribution

  • 00822383135441 ()


  • General-purpose patient lifting system sling/harness
Tennis Elbow Brace (New, Black Exterior Blue Interior)
VIVE HEALTH LLC
SUP1083BLU
In Commercial Distribution

  • 10818323022442 ()
  • 00818323022445 ()


  • Elbow immobilizer
Tennis Elbow Brace (New, Black Exterior Pink Interior)
VIVE HEALTH LLC
SUP1083PNK
In Commercial Distribution

  • 10818323022435 ()
  • 00818323022438 ()


  • Elbow immobilizer
Tennis Elbow Brace (New, Black Exterior Teal Interior)
VIVE HEALTH LLC
SUP1083TAL
In Commercial Distribution

  • 10818323022428 ()
  • 00818323022421 ()


  • Elbow immobilizer
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