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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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Biotem - 08800036204135

Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB604EW
In Commercial Distribution

  • 08800036204135 ()


  • Dental implant system

Biotem - 08800036204128

Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB40437
In Commercial Distribution

  • 08800036204128 ()


  • Dental implant system

Biotem - 08800036204111

Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB40435
In Commercial Distribution

  • 08800036204111 ()


  • Dental implant system

Biotem - 08800036204104

Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB40434
In Commercial Distribution

  • 08800036204104 ()


  • Dental implant system

Biotem - 08800036204098

Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAIT40437
In Commercial Distribution

  • 08800036204098 ()


  • Dental implant system

ARCHITECT - 00380740003883

ARCHITECT HIV Ag/Ab Combo Controls
Abbott GmbH
2P36-10
In Commercial Distribution

  • 00380740003883 ()
02P3610

  • HIV1/HIV2 antigen/antibody IVD, control

ARCHITECT - 00380740003876

ARCHITECT HIV Ag/Ab Combo Calibrator
Abbott GmbH
2P36-01
In Commercial Distribution

  • 00380740003876 ()
02P3601

  • HIV1/HIV2 antigen/antibody IVD, calibrator

Shani Darden LED Light Therapy Mask - 05060534510517

Shani Darden Branded Facemask Blue, Red & NIR facemask
I-SMART DEVELOPMENTS LIMITED
TN2118
In Commercial Distribution

  • 05060534510517 ()
115-HGSD

  • Blue/red/infrared phototherapy lamp

Tester - 20643169975105

PLUG MMT-7736L TEST LOCKOUT 2PK EN
MEDTRONIC MINIMED, INC.
MMT-7736L
In Commercial Distribution

  • 20643169975105 ()
  • 00643169975101 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Extended Reservoir™ - 00763000837259

RSVR MMT-342G 5PK EW 3ML US
MEDTRONIC MINIMED, INC.
MMT-342G
In Commercial Distribution

  • 00763000837259 ()


  • General-purpose syringe, single-use

Skintact - 19005531592022

ECG Electrodes
Leonhard Lang GmbH
FS-TB1 /5 -5
In Commercial Distribution

  • 39005531592026 ()
  • 29005531592029 ()
  • 19005531592022 ()
  • 09005531592025 ()
FS-TB1 /5 -5

  • Electrocardiographic electrode, single-use

Ultra 5 - 00852598007349

Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007349 ()


  • Penile vacuum device

Select 5 - 00852598007318

Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007318 ()


  • Penile vacuum device

DVVconfirm 5 - 00850201006024

No Description
Biomedica ADI Inc.
815
In Commercial Distribution

  • 00850201006024 ()
  • 10850201006021 ()
815

  • Lupus anticoagulant marker IVD, kit, clotting

MCT 5 - 05708590389882

MCT 5 change trolley, 700 x 2100 mm, two fold-down sides, white. Manually height adjustable with foot pedal
Pressalit A/S
R95027
In Commercial Distribution

  • 05708590389882 ()
R9502721000

  • Bathing/changing table, mobile

MCT 5 - 05708590389875

MCT 5 change trolley, 700 x 1900 mm, two fold-down sides, white. Manually height adjustable with foot pedal
Pressalit A/S
R95027
In Commercial Distribution

  • 05708590389875 ()
R9502719000

  • Bathing/changing table, mobile

MCT 5 - 05708590389868

MCT 5 change trolley, 700 x 1700 mm, two fold-down sides, white. Manually height adjustable with foot pedal
Pressalit A/S
R95027
In Commercial Distribution

  • 05708590389868 ()
R9502717000

  • Bathing/changing table, mobile

TRIOS 5 - 05902729754149

The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes one TST-11 tip.
3shape Trios A/S
L1P-1F
In Commercial Distribution

  • 05902729754149 ()


  • Intraoral optical scanning system

TRIOS 5 - 05902729753739

No Description
3shape Trios A/S
L1-2
In Commercial Distribution

  • 05902729753739 ()


  • Intraoral optical scanning system

TRIOS 5 - 05902729753722

The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes five TST-11 tips.
3shape Trios A/S
L1P-1F
In Commercial Distribution

  • 05902729753722 ()


  • Intraoral optical scanning system
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