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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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PRE-MADE REP. POST STRAIGHT - D7700874753

PRE-MADE REP. POST STRAIGHT PROF.,H4, PREKOH TG
SWEDEN & MARTINA SPA
A-TG-MR-W-40
In Commercial Distribution

  • D7700874753 ()
A-TG-MR-W-40

  • Dental implant suprastructure, permanent, preformed

PRE-MADE REP. POST STRAIGHT - D7700874743

PRE-MADE REP. POST STRAIGHT PROF.,H4, PREKOH TG
SWEDEN & MARTINA SPA
A-TG-MR-M-40
In Commercial Distribution

  • D7700874743 ()
A-TG-MR-M-40

  • Dental implant suprastructure, permanent, preformed

SOLID ONE-PIECE ABUTMENT, H7MM - D7700874733

SOLID ONE-PIECE ABUTMENT, H7MM PRE-KOH TG, WIDE PLATFORM
SWEDEN & MARTINA SPA
A-TG-MD-W-70
In Commercial Distribution

  • D7700874733 ()
A-TG-MD-W-70

  • Dental implant suprastructure, permanent, preformed

SOLID ONE-PIECE ABUTMENT, H7MM - D7700874723

SOLID ONE-PIECE ABUTMENT, H7MM PRE-KOH TG, MEDIUM PLATFORM
SWEDEN & MARTINA SPA
A-TG-MD-M-70
In Commercial Distribution

  • D7700874723 ()
A-TG-MD-M-70

  • Dental implant suprastructure, permanent, preformed

SOLID ONE-PIECE ABUTMENT, H4MM - D7700874713

SOLID ONE-PIECE ABUTMENT, H4MM PRE-KOH TG, WIDE PLATFORM
SWEDEN & MARTINA SPA
A-TG-MD-W-40
In Commercial Distribution

  • D7700874713 ()
A-TG-MD-W-40

  • Dental implant suprastructure, permanent, preformed

SOLID ONE-PIECE ABUTMENT, H4MM - D7700874703

SOLID ONE-PIECE ABUTMENT, H4MM PRE-KOH TG, MEDIUM PLATFORM
SWEDEN & MARTINA SPA
A-TG-MD-M-40
In Commercial Distribution

  • D7700874703 ()
A-TG-MD-M-40

  • 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 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

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

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

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

NA - 20613994747895

SCREW SR-6000 6mm f/Stimloc f/TG AIMD
MEDTRONIC, INC.
SR-6000
In Commercial Distribution

  • 20613994747895 ()
  • 00613994747891 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

BEVEL - 00810109930715

ANGKOR WAT - TG - Toffee Grain - 48 * 18 - 135
Incite International Inc
2544TG
In Commercial Distribution

  • G1312544TG0 ()
  • 00810109930715 ()


  • Spectacle frame

Clarius Ultrasound Scanner - 07540205000397

No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software

Lilly Together - 00300021107550

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices.
ELI LILLY AND COMPANY
MA7723 IOS
In Commercial Distribution

  • 00300021107550 ()
MA7723001AM

  • Medication reminder application software

Miracle Ear App - 00860001471724

Also covers the following minor/medium updates: v3.1.0 (01)00860001471724(11)210526(10)310; v3.1.1 (01)00860001471724(11)210604(10)311; v3.1.2 (01)00860001471724(11)210625(10)312; v3.2.0 (01)00860001471724(11)210713(10)320; v3.2.1. (01)00860001471724(11)210804(10)321; v3.2.2 (01)00860001471724(11)210917(10)322; v3.2.3 (01)00860001471724(11)211026(10)323 ;v3.2.4 (01)00860001471724(11)211123(10)324; v3.7.0 (01)00860001471724(11) 221116(10)370; v3.6.2 (01)00860001471724(11) 221024(10)362; v3.4.0:(01)00860001471724(11)220609(10)350; v3.5.1(01)00860001471724(11)220718(10)351; v3.6.0 (01)00860001471724(11) 220926(10)360; v3.8.0 (01)00860001471724(11) 221215(10)380; v3.8.1 (01)00860001471724(11) 230127(10)381; v3.9.0 (01)00860001471724(11) 230217(10)390; v3.9.1 (01)00860001471724(11) 230417(10)391; v3.9.2 (01)00860001471724(11) 230609(10)392; v3.9.3 (01)00860001471724(11) 230714(10)393; v3.10.0 (01)00860001471724(11) 231013(10)3100
AMPLIFON SPA
iOS v3
In Commercial Distribution

  • 00860001471724 ()


  • Hearing aid/implant system remote control

NewTom - 08033837932970

The device is an optical impression system. It is used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
NewTom IOS
In Commercial Distribution

  • 08033837932970 ()
70960000

  • Intraoral optical scanning system
  • Dental milling system, CAD/CAM, chairside

XVS Headset Battery SMALL - 07290113780323

No Description
AUGMEDICS LTD
ABAT00002
In Commercial Distribution

  • 07290113780323 ()


  • Multi-purpose stereotactic surgery system

XVS Headset Battery LARGE - 07290113780316

No Description
AUGMEDICS LTD
ABAT00001
In Commercial Distribution

  • 07290113780316 ()


  • Multi-purpose stereotactic surgery system

XVS Headset Battery Charger - 07290113780309

No Description
AUGMEDICS LTD
APWR0004
In Commercial Distribution

  • 07290113780309 ()


  • Multi-purpose stereotactic surgery system

XVS STERILE COMPONENTS KIT - 07290113780101

No Description
AUGMEDICS LTD
ASP00014
In Commercial Distribution

  • 17290113780108 ()
  • 07290113780101 ()
  • 27290113780105 ()


  • Multi-purpose stereotactic surgery system

XVS STERILE COMPONENTS KIT - 07290113780989

No Description
AUGMEDICS LTD
ASP00050
In Commercial Distribution

  • 17290113780986 ()
  • 07290113780989 ()


  • Multi-purpose stereotactic surgery system

1/8 pigtail - 00607567207004

No Description
DATASCOPE CORP.
BO-T 31205
Not in Commercial Distribution

  • 00607567207004 ()
70900009

  • Cardiopulmonary bypass system blood tubing set

Table Line Pack - 00607567206953

No Description
DATASCOPE CORP.
BO-T 25106
Not in Commercial Distribution

  • 00607567206953 ()
701068046

  • Cardiopulmonary bypass system blood tubing set

Rotaflow - 00607567206793

BO-RF32 RotaFlow
DATASCOPE CORP.
BO-T 39102
Not in Commercial Distribution

  • 00607567206793 ()
701064307

  • Cardiopulmonary bypass system blood tubing set

3/8 Handup Pack - 00607567206557

No Description
DATASCOPE CORP.
BO-T 20208
Not in Commercial Distribution

  • 00607567206557 ()
701067396

  • Cardiopulmonary bypass system blood tubing set

1/4 Handup Pack - 00607567206540

No Description
DATASCOPE CORP.
BO-T 20207
Not in Commercial Distribution

  • 00607567206540 ()
701067394

  • Cardiopulmonary bypass system blood tubing set

ECC Ancilliary pack - 00607567206236

No Description
DATASCOPE CORP.
BO-T 4115
Not in Commercial Distribution

  • 00607567206236 ()
701067206

  • Cardiopulmonary bypass system blood tubing set

Tubing Pack 1/4" w/o Oxygenator - 00607567206014

Better Bladder 1/4, Blood Microfilter System SQ 40 S, Gas Filter
DATASCOPE CORP.
BO-T 4100
Not in Commercial Distribution

  • 00607567206014 ()
701066836

  • Cardiopulmonary bypass system blood tubing set

Cardioplegia Accessory Pack - 00607567205802

No Description
DATASCOPE CORP.
BO-T 30301
Not in Commercial Distribution

  • 00607567205802 ()
701066188

  • Cardioplegia solution administration kit

Cardioplegia Dual Line Pack - 00607567205079

No Description
DATASCOPE CORP.
BO-T 36501
Not in Commercial Distribution

  • 00607567205079 ()
701064513

  • Cardioplegia solution administration kit

ECC 1/4 - 00607567205000

Softshell Venous Reser. 1900ml w. connector 700000292, BO-RF32 RotaFlow, CDI Sat Cell 1/4" System 100,
DATASCOPE CORP.
BO-T 21306
Not in Commercial Distribution

  • 00607567205000 ()
701064000

  • Cardiopulmonary bypass system blood tubing set

Mayo Pulmonary Pk. Softline - 00607567204980

Softshell Venous Reser. 1900ml CDI Sat Cell 3/8" System 100 Gas Filter
DATASCOPE CORP.
BO-T 44201
Not in Commercial Distribution

  • 00607567204980 ()
701064834

  • Cardiopulmonary bypass system blood tubing set

ECC PAck - 00607567204485

Gas Filter
DATASCOPE CORP.
BO-T 25101
Not in Commercial Distribution

  • 00607567204485 ()


  • Cardiopulmonary bypass system blood tubing set

10 Ft. 3/8 x 3/32 Tubing - 00607567204430

No Description
DATASCOPE CORP.
BO-T 20105
Not in Commercial Distribution

  • 00607567204430 ()
701048450

  • Cardiopulmonary bypass system blood tubing set

6ft 3/8x3/32 Tubing - 00607567204423

No Description
DATASCOPE CORP.
BO-T 20104
Not in Commercial Distribution

  • 00607567204423 ()
701048444

  • Cardiopulmonary bypass system blood tubing set

6ft 1/4x1/16 Tubing - 00607567204416

No Description
DATASCOPE CORP.
BO-T 20102
Not in Commercial Distribution

  • 00607567204416 ()
701048433

  • Cardiopulmonary bypass system blood tubing set

10ft 1/2x3/32 Tubing - 00607567204409

No Description
DATASCOPE CORP.
BO-T 20101
In Commercial Distribution

  • 00607567204409 ()
701048426

  • Cardiopulmonary bypass system blood tubing set
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