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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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Nellcor - 10884521815469

Forehead SpO2 Sensor
Covidien LP
MAXFASTI
In Commercial Distribution

  • 20884521815466 ()
  • 10884521815469 ()

  • Patient Weight, Greater than or Equal to 10, KG;


  • Pulse oximeter probe, single-use

Nellcor - 10884521815360

Forehead SpO2 Sensor
Covidien LP
MAXFAST
In Commercial Distribution

  • 20884521815367 ()
  • 10884521815360 ()

  • Patient Weight, Greater than or Equal to 10, KG;


  • Pulse oximeter probe, single-use

WIRE/PIN CUTTER - 00192896051447

WIRE/PIN CUTTER DOUBLE ACTION ANGLED TUNGSTEN CARBIDE BLADES
SONTEC INSTRUMENTS, INC.
1103-103V
In Commercial Distribution

  • 00192896051447 ()

  • 30 Degree Tip
  • For wire up to 2.2 Millimeter
  • Length: 8.75 Inch
1103-103V

  • Orthopaedic implantable-device cutter

WIRE/PIN CUTTER - 00192896051430

WIRE/PIN CUTTER DOUBLE ACTION ANGLED TUNGSTEN CARBIDE BLADES
SONTEC INSTRUMENTS, INC.
1103-102
In Commercial Distribution

  • 00192896051430 ()

  • 15 Degree Tip
  • For wire up to 2.2 Millimeter
  • Length: 8.75 Inch
1103-102

  • Orthopaedic implantable-device cutter

Nellcor - 10884522039710

Forehead SpO2 Sensor
Covidien LP
MAXFAST
In Commercial Distribution

  • 20884522039717 ()
  • 10884522039710 ()

  • Patient Weight, Greater than or Equal to 10, KG;


  • Pulse oximeter probe, single-use

Gelfilm - 00300090297015

Anti-adhesion dressing, bioabsorbable
PHARMACIA & UPJOHN COMPANY LLC
Gelfilm® Sterile Ophthalmic Film Ophthalmic film 6's (12.5 sq cm)
In Commercial Distribution

  • 00300090297039 ()
  • 00300090297015 ()

  • Length: 50 Millimeter
  • Thickness of film ranges from 0.060 to 0.175 mm
  • Width: 25 Millimeter


  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated

MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50 - 04260764840687

The MedibinoNeo positioning ring has to be used with a fitting cover during clinical usage. These disposable covers have a cenral inner filling with soft granules and are fitting for the MedibinoNeo ring size M.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840830 ()
  • 04260764840687 ()

  • Accessory, that fits to MedibinoNeo gel ring Size M
31021703-M

  • Infant recumbent sleep positioner

Nellcor - 20884522039694

Forehead SpO2 Sensor
Covidien LP
MAXFASTI
In Commercial Distribution

  • 10884522039697 ()
  • 20884522039694 ()

  • Patient Weight, Greater than or Equal to 10, KG;


  • Pulse oximeter probe, single-use

Gelfilm - 10300090283015

Anti-adhesion dressing, bioabsorbable
PHARMACIA & UPJOHN COMPANY LLC
Gelfilm® Sterile Film Sterile film 1's (125 sq cm)
In Commercial Distribution

  • 10300090283015 ()

  • Length: 125 Millimeter
  • Thickness of film ranges from 0.060 to 0.175 mm
  • Width: 100 Millimeter


  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated

Tatum Surgical Custom Abutment (Post) - 00083208700002

Implant Abutment neck diameter ( 3.5 to 5.0mm), 9mm height, between 40° and 60° as required - prescribed for patient by Dentist
Suncoast Dental, Inc
Custom Abutment
Not in Commercial Distribution

  • 00083208700002 ()

  • Height: 9 Millimeter
  • Custom Implant Abutment Angle between 40° and 60°
Custom PN 40° to 60°

  • Screw endosteal dental implant, two-piece

TUTEM - 00817583020406

EARLOOP, TUTEM- KEEP IT TO YOURSELF.
Alpha Pro Tech, Inc.
6055-6 KEEP IT TO YOURSELF
Not in Commercial Distribution

  • 10817583020403 ()
  • 00817583020406 ()
6055-6 KEEP IT TO YOURSELF

  • Surgical hood

Norav 1200 Series PC-ECG - 07290110252717

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Upgrade from SOFT-NH300-2/3 to SOFT-NH301-4,K The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 Ana to 301
In Commercial Distribution

  • 07290110252717 ()
SW NH300 Ana to 301

  • Electrocardiographic long-term ambulatory recording analyser

Orantech - 06941691969327

Replacement Disposable Sidestream ETCO2 Capnotrak Airway Adapter Set 4.0mm For Adult Respironics 1103414 Philips 989803198991
Orantech Inc.
TNC-RP-AA001
In Commercial Distribution

  • 06941691969327 ()


  • Anaesthesia workstation common gas outlet

Lucid Audio - 00846430005839

Tala Android - OTC Hearing aid Ety part #20138
ETYMOTIC RESEARCH, INC.
Tala Android
In Commercial Distribution

  • 00846430005839 ()


  • Air-conduction hearing aid, in-the-ear

Lilly Together - 00300021109554

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers).
ELI LILLY AND COMPANY
MA9131 Android
In Commercial Distribution

  • 00300021109554 ()
MA9131001AM

  • Medication reminder application software

Slide.fit - 04048817590150

donning aid for transfemoral prostheses, size XXL, dark grey / orange
Streifeneder ortho.production GmbH
17A1/XXL
In Commercial Distribution

  • 04048817590150 ()

  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
17A1/XXL

  • Mechanical-resistance external knee prosthesis

Slide.fit - 04048817590143

donning aid for transfemoral prostheses, size XL, dark grey / light blue
Streifeneder ortho.production GmbH
17A1/XL
In Commercial Distribution

  • 04048817590143 ()

  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
17A1/XL

  • Mechanical-resistance external knee prosthesis

Slide.fit - 04048817590136

donning aid for transfemoral prostheses, size L, dark grey / green
Streifeneder ortho.production GmbH
17A1/L
In Commercial Distribution

  • 04048817590136 ()

  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
17A1/L

  • Mechanical-resistance external knee prosthesis

Slide.fit - 04048817590129

donning aid for transfemoral prostheses, size M, dark grey / dark blue
Streifeneder ortho.production GmbH
17A1/M
In Commercial Distribution

  • 04048817590129 ()

  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
17A1/M

  • Mechanical-resistance external knee prosthesis

Slide.fit - 04048817590112

donning aid for transfemoral prostheses, size S, dark grey / red
Streifeneder ortho.production GmbH
17A1/S
In Commercial Distribution

  • 04048817590112 ()

  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
17A1/S

  • Mechanical-resistance external knee prosthesis

Slide.fit - 04048817590105

donning aid for transfemoral prostheses, size XS, dark grey / yellow
Streifeneder ortho.production GmbH
17A1/XS
In Commercial Distribution

  • 04048817590105 ()

  • size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm
  • size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm
  • size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm
  • size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm
  • size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm
  • size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm
17A1/XS

  • Mechanical-resistance external knee prosthesis

Power Dental USA - D9432001T00

SURGICAL CHISELS 13K/TG TITANIUM 3.5 / 3 mm
Power Dental U.S.A. Inc.
2001T
In Commercial Distribution

  • D9432001T00 ()
2001T

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe

MEDI - 00636257156186

TG 8MM 3# FOAM CONDYLAR BK/BK HOOK
MEDI MANUFACTURING, INC.
201561
In Commercial Distribution

  • 00636257156186 ()


  • Knee support orthosis

XiVE® - EFRI322593012

XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32259301
Not in Commercial Distribution

  • EFRI322593012 ()
25-9301

  • Dental implant suprastructure kit

XiVE® - EFRI322541062

XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32254106
Not in Commercial Distribution

  • EFRI322541062 ()
25-4106

  • Dental implant suprastructure kit

XiVE® - EFRI322541052

XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32254105
Not in Commercial Distribution

  • EFRI322541052 ()
25-4105

  • Dental implant suprastructure kit

XiVE® - EFRI322596002

XiVE® TG Lab Set Gold Bar Coping
Dentsply Implants Manufacturing GmbH
32259600
Not in Commercial Distribution

  • EFRI322596002 ()
25-9600

  • Dental implant suprastructure kit

XiVE® - EFRI322593002

XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32259300
Not in Commercial Distribution

  • EFRI322593002 ()
25-9300

  • Dental implant suprastructure kit

ADVIA Centaur® aTG MCM - 00630414580722

TG Ab Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492692
In Commercial Distribution

  • 00630414580722 ()
10492692

  • Thyroglobulin antibody IVD, control

T-CONNECT FOR SINGLE - D7701023833

T-CONNECT FOR SINGLE CROWN PRE/KOH TG W
SWEDEN & MARTINA SPA
A-TG-BASTZR-S-W
In Commercial Distribution

  • D7701023833 ()
A-TG-BASTZR-S-W

  • Dental implant suprastructure, permanent, preformed

T-CONNECT FOR SINGLE - D7701002123

T-CONNECT FOR SINGLE CROWN PRE/KOH TG M
SWEDEN & MARTINA SPA
A-TG-BASTZR-S-M
In Commercial Distribution

  • D7701002123 ()
A-TG-BASTZR-S-M

  • Dental implant suprastructure, permanent, preformed

TRANSFER ECHO FOR PRE-KOH TG - D7700887003

TRANSFER ECHO FOR PRE-KOH TG IMPLANTS, WIDE PLATFORM
SWEDEN & MARTINA SPA
A-TG-CAMTRA-W
In Commercial Distribution

  • D7700887003 ()
A-TG-CAMTRA-W

  • Dental implant/prosthesis surgical procedure kit

TRANSFER ECHO FOR PRE-KOH TG - D7700886993

TRANSFER ECHO FOR PRE-KOH TG IMPLANTS, MEDIUM PLATFORM
SWEDEN & MARTINA SPA
A-TG-CAMTRA-M
In Commercial Distribution

  • D7700886993 ()
A-TG-CAMTRA-M

  • Dental implant/prosthesis surgical procedure kit

SCREW M2 FOR RIP.ABUTMENT - D7700884153

SCREW M2 FOR RIP.ABUTMENT PRE-KOH TG, WIDE, MAGENTA
SWEDEN & MARTINA SPA
A-TG-VABUR-W
In Commercial Distribution

  • D7700884153 ()
A-TG-VABUR-W

  • Dental implant suprastructure, permanent, preformed

SCREW M1.8 FOR RIP.ABUTMENT - D7700884143

SCREW M1.8 FOR RIP.ABUTMENT PRE-KOH TG, MEDIUM, GREEN
SWEDEN & MARTINA SPA
A-TG-VABUR-M
In Commercial Distribution

  • D7700884143 ()
A-TG-VABUR-M

  • Dental implant suprastructure, permanent, preformed

ANALOGUE FOR PRE-KOH TG ABUT. - D7700880673

ANALOGUE FOR PRE-KOH TG ABUT. WIDE PLATFORM, MAGENTA
SWEDEN & MARTINA SPA
A-TG-ANABU-W
In Commercial Distribution

  • D7700880673 ()
A-TG-ANABU-W

  • Dental implant suprastructure, permanent, preformed

ANALOGUE FOR PRE-KOH TG ABUT. - D7700880663

ANALOGUE FOR PRE-KOH TG ABUT. MEDIUM PLATFORM, GREEN
SWEDEN & MARTINA SPA
A-TG-ANABU-M
In Commercial Distribution

  • D7700880663 ()
A-TG-ANABU-M

  • Dental implant suprastructure, permanent, preformed

HEALING CAP FOR ABUTMENT - D7700880523

HEALING CAP FOR ABUTMENT PRE-KOH TG, WIDE PLATFORM
SWEDEN & MARTINA SPA
A-TG-CAPGABU-W
In Commercial Distribution

  • D7700880523 ()
A-TG-CAPGABU-W

  • Dental implant suprastructure, permanent, preformed

HEALING CAP FOR ABUTMENT - D7700880513

HEALING CAP FOR ABUTMENT PRE-KOH TG, MEDIUM PLATFORM
SWEDEN & MARTINA SPA
A-TG-CAPGABU-M
In Commercial Distribution

  • D7700880513 ()
A-TG-CAPGABU-M

  • Dental implant suprastructure, permanent, preformed

NON REP. ABUTMENT FOR - D7700880483

NON REP. ABUTMENT FOR PRE-KOH TG WIDE PLATFORM
SWEDEN & MARTINA SPA
A-TG-ABUD-W
In Commercial Distribution

  • D7700880483 ()
A-TG-ABUD-W

  • Dental implant suprastructure, permanent, preformed
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