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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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Gel Etchant - D7981EGSS0

Gel Etchant is intended for use in the etching of enamel surface prior to bonding. This is a 6.5gm push syringe of gel etchant.
RELIANCE ORTHODONTIC PRODUCTS INC
1EGSS
In Commercial Distribution

  • D7981EGSS0 ()
1EGSS

  • Dental etching solution

Excel Fast - D7981EFSAF0

Excel Fast is intended for use as a bracket adhesive. This is the Fast Set adhesive Part A with Fluoride in a 6gm syringe
RELIANCE ORTHODONTIC PRODUCTS INC
1EFSAF
In Commercial Distribution

  • D7981EFSAF0 ()
1EFSAF

  • Orthodontic bracket adhesive

Band Lok - D798SMBLB0

Band Lok is a two paste dual-cure adhesive intended for use as a band cement. This is for Self Mixing dispensing in Blue Shade.
RELIANCE ORTHODONTIC PRODUCTS INC
SMBLB
In Commercial Distribution

  • D798SMBLB0 ()
SMBLB

  • Dental composite resin

Titan™ - 10381780247371

Titan™ Reverse Shoulder System The torx-25 screwdriver shaft with quick connect is used to advance the screw just before it is fully seated.
Ascension Orthopedics, Inc.
SCR096007201
In Commercial Distribution

  • M269SCR0960072011 ()
  • 10381780247371 ()

  • 9.80 in L
SCR-0960-072-01

  • Surgical screwdriver, reusable

Cadence™ - 10381780240709

Screwdriver Handle is used in conjunction with the AO Hex Driver to assemble a AO Hex Screwdriver and is used to tighten locking screws
Ascension Orthopedics, Inc.
10204145
In Commercial Distribution

  • M268102041451 ()
  • 10381780240709 ()

  • 5.26in L x 1in diameter
10204145

  • Surgical instrument handle, non-torque-limiting

Cadence™ - 10381780240280

Cadence Tibial Impactor Tip is attached to the tibial impactor handle and is used to seat the Tibial Tray Implant on the distal tibia.
Ascension Orthopedics, Inc.
10203100
Not in Commercial Distribution

  • M268102031001 ()
  • 10381780240280 ()


  • Orthopaedic implant/instrument assembling device

iQ-SYSTEM PACS - B403IQS130

iQ-SYSTEM PACS is a software device for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting.
IMAGE Information Systems Europe GmbH
1.3
In Commercial Distribution

  • B403IQS130 ()


  • Radiology picture archiving and communication system digital archive device

iQ-SYSTEM PACS - B403IQS120

iQ-SYSTEM PACS is a software device for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting.
IMAGE Information Systems Europe GmbH
1.2
In Commercial Distribution

  • B403IQS120 ()


  • Radiology picture archiving and communication system digital archive device

KardiaMobile Card - B210AC0210

The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG) device that is intended to record, store, transfer, display, and analyze single-channel ECG rhythms.
Alivecor, Inc.
AC-021
In Commercial Distribution

  • B210AC0210 ()


  • Electrocardiograph, professional, single-channel
  • Electrocardiograph, home-use

Napsin A RMab - B502BSB69930

Anti-Napsin A is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB69930 ()
BSB 6993

  • Napsin A IVD, antibody
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