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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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Orthopli - D917OL110

Lap Joint How Plier
ORTHOPLI CORP.
OL-11
In Commercial Distribution

  • D917OL110 ()


  • Orthodontic pliers

ORTHOSOURCE - D9118711040

Superb How Band Seating
ORTHOSOURCE
871-104
In Commercial Distribution

  • D9118711040 ()


  • Orthodontic pliers

N.A. - J011045006000

How pliers, straight, EQ-Line
DENTAURUM GmbH & Co.KG
045-006-00
In Commercial Distribution

  • J011045006000 ()


  • Orthodontic pliers

N.A. - J011003112000

How pliers, straight, Premium-Line
DENTAURUM GmbH & Co.KG
003-112-00
In Commercial Distribution

  • J011003112000 ()


  • Orthodontic pliers

N.A. - J011003111000

How pliers, curved, Premium-Line
DENTAURUM GmbH & Co.KG
003-111-00
In Commercial Distribution

  • J011003111000 ()


  • Orthodontic pliers

Surgical Direct - B382SD902972030

How Utility Pliers, Straight
Surgical Direct, Inc.
SD90297203
In Commercial Distribution

  • B382SD902972030 ()
SD90297203

  • Dressing/utility forceps, scissors-like, reusable

J&J Instruments - 00817524023831

HOW PLIER #111 CVD
J & J INSTRUMENTS INC
09-111
In Commercial Distribution

  • 00817524023831 ()


  • Orthodontic pliers

J&J Instruments - 00817524023824

HOW PLIER #110 STR
J & J INSTRUMENTS INC
09-110
In Commercial Distribution

  • 00817524023824 ()


  • Orthodontic pliers

SCHWERT - E89653210

How pliers straight, modified
A. Schweickhardt GmbH & Co. KG
5321
In Commercial Distribution

  • E89653210 ()
5321

  • Wire holding/twisting pliers

Triumph® - 00190707081638

Triumph® How Pliers
ORTHO ORGANIZERS, INC.
205-203
In Commercial Distribution

  • 00190707081638 ()


  • Orthodontic pliers

X7 - 00190730083753

Standard How Utility Plier
ORTHO TECHNOLOGY, INC.
400-115
Not in Commercial Distribution

  • 00190730083753 ()


  • Orthodontic pliers

Orthoquest - 00840326408551

How Utility Plier Straight
Young Innovations, Inc.
G009
In Commercial Distribution

  • 10840326408558 ()
  • 00840326408551 ()
G009

  • Orthodontic pliers

Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application - 00855093008002

Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution

  • 00855093008002 ()


  • Clinical management support software

Healthweigh - 00850042373255

Scale, Digital Home Health Model DHH-10BT 440lb (200kg) x0.2lb (0.1kg) 300mm (L) x 360mm (W) x 8mm (H) includes (2) AAA batteries, tempered glass Includes Bluetooth connectivity compatible with Apple Health and Google Health APP
Rice Lake Weighing Systems, Inc.
DHH-10BT
In Commercial Distribution

  • 00850042373255 ()
201125

  • Stand-on floor scale, electronic

ZEISS CONNECT - 04049539070135

The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.). This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420
Carl Zeiss Meditec AG
2.0
In Commercial Distribution

  • 04049539070135 ()


  • Multidisciplinary medical image management software

Parky - 00860009869707

Parky App is a symptom tracker mobile app for Parkinson’s Disease patients. It collects motion data through Apple Watch continuously and quantifies tremor and dyskinesia episodes based on clinically validated MM4PD algorithm. Tracked symptoms are reported as daily, weekly and monthly. Each report is shared with the prescribing healthcare professional through email.
H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI
V1
In Commercial Distribution

  • 00860009869707 ()


  • Tremor transducer

Assure - D798APP0

Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention.
RELIANCE ORTHODONTIC PRODUCTS INC
APP
In Commercial Distribution

  • D798APP0 ()
APP

  • Orthodontic bracket adhesive

BENCO - 00366975004833

Orthodontic How Pliers Curved, #111
BENCO DENTAL SUPPLY CO.
5094-006
In Commercial Distribution

  • 00366975004833 ()


  • Orthodontic pliers

BENCO - 00366975004741

Dental How Straight Pliers, #110
BENCO DENTAL SUPPLY CO.
5093-990
In Commercial Distribution

  • 00366975004741 ()


  • Orthodontic pliers

Power Dental USA - D9435613

ORTHODONTIC PLIER HOW STR LONG
Power Dental U.S.A. Inc.
5613
Not in Commercial Distribution

  • D9435613 ()
5613

  • Orthodontic pliers

J & J INSTRUMENTS - 00817524026641

HOW PLIER #110 STR ELITE
J & J INSTRUMENTS INC
29-110
In Commercial Distribution

  • 00817524026641 ()


  • Orthodontic pliers

Surgical Direct - B382SD56130

Orthodontic Plier How Straight Long
Surgical Direct, Inc.
SD5613
In Commercial Distribution

  • B382SD56130 ()
SD5613

  • Dental rongeur

X7 - 00190730030863

X7 Standard How Utility Plier
ORTHO TECHNOLOGY, INC.
400-115
In Commercial Distribution

  • 00190730030863 ()


  • Orthodontic pliers

Darby Dental Supply, LLC - 00889813039144

PLIER HOW STRAIGHT 110 DARBY
DARBY DENTAL SUPPLY, LLC
9518150
In Commercial Distribution

  • 00889813039144 ()
9518150

  • Orthodontic pliers

Darby Dental Supply, LLC - 00889813039137

PLIER HOW CURVED 111 DARBY
DARBY DENTAL SUPPLY, LLC
9518148
In Commercial Distribution

  • 00889813039137 ()
9518148

  • Orthodontic pliers

Luno - 00190746142109

INSTRUMENT LUNO HOW PLIERS OFFSET
AMERICAN ORTHODONTICS CORPORATION
001-023352
In Commercial Distribution

  • 00190746142109 ()
001-023352

  • Orthodontic pliers

Luno - 00190746142093

INSTRUMENT LUNO HOW PLIERS STRAIGHT
AMERICAN ORTHODONTICS CORPORATION
001-023351
In Commercial Distribution

  • 00190746142093 ()
001-023351

  • Orthodontic pliers

Apex - 00885797119049

APEX SERIES HOW PLIER (STRAIGHT)
Rmo, Inc.
T00112
In Commercial Distribution

  • 00885797119049 ()


  • Orthodontic pliers

Nuvo XS - B660RMNXS0

Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXS
In Commercial Distribution

  • B660RMNXS0 ()


  • Voice synthesizer/digitizer

Nuvo XL - B660RMNXL0

Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXL
In Commercial Distribution

  • B660RMNXL0 ()


  • Voice synthesizer/digitizer
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