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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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SciPharm Anterior/Posterior Restoratives - D801SP540421

Visible Light-Cured, Resin-Based Composite Restorative Paste/Paste Type. 7 gram Jar, Part B.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 54-042
In Commercial Distribution

  • D801SP540421 ()
54-042

  • Dental composite resin

Bosworth Trim - H6680921900L1

PEMA Temp C&B Light Pwd Kit, 2-3 oz Pwd, 6 oz liquid
Harry J Bosworth Company
0921900L
In Commercial Distribution

  • H6680921900L1 ()
0921900L

  • Temporary dental crown/bridge resin

Bosworth Trim - H6680921900D1

PEMA Temp C&B Dark Pwd Kit, 2-3 oz Pwd, 6 oz liquid
Harry J Bosworth Company
0921900D
In Commercial Distribution

  • H6680921900D1 ()
0921900D

  • Temporary dental crown/bridge resin

NA - M595S3940

‘A’ Gel Universal Dentin Activator 5ml. for C&B METABOND® & AMALGAMBOND®
PARKELL, INC.
S394
Not in Commercial Distribution

  • M595S3940 ()
S394

  • Dental etching solution

iTotal Identity CR - M572RCR020000B141

ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, B, LEFT & RIGHT
Conformis, Inc.
RCR020000B14
In Commercial Distribution

  • M572RCR020000B141 ()
RCR-020-000B

  • Tibial insert

iTotal® CR iPoly® XE Insert Kit - M572RCR020000B131

ITOTAL CR IPOLY XE LATERAL B INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000B13
In Commercial Distribution

  • M572RCR020000B131 ()

  • Patient Specific
RCR020000B

  • Tibial insert

NA - M595S3930

‘A’ Liquid Universal Dentin Activator 6ml. for C&B METABOND® & AMALGAMBOND®
PARKELL, INC.
S393
Not in Commercial Distribution

  • M595S3930 ()
S393

  • Dental etching solution

Integra® Padgett® - 10381780278009

Integra® Padgett® Dermatomes Power supply (120V) Model B - USA/Canada Only
INTEGRA LIFESCIENCES CORPORATION
DP0002
In Commercial Distribution

  • M248DP00021 ()
  • 10381780278009 ()
DP0002

  • Basic power supply, reusable

NeuroTrace - B33955625040

Insulated Electro-Needle for use in Regional Anesthesia, 25ga x 1.5" (38mm) , B Bevel
Neo Medical Inc.
556-25-04
In Commercial Distribution

  • B33955625040 ()
  • B33955625045 ()

  • Length: 38 Millimeter
  • Length: 1.5 Inch
  • Needle Gauge: 25 Gauge
556-25-04

  • Nerve-locating anaesthesia needle

NeuroTrace - B33955325040

Insulated Electro-Needle for use in Regional Anesthesia, 25ga x 1.5" (38mm), B Bevel
Neo Medical Inc.
553-25-04
In Commercial Distribution

  • B33955325040 ()
  • B33955325045 ()

  • Length: 38 Millimeter
  • Length: 1.5 Inch
  • Needle Gauge: 25 Gauge
553-25-04

  • Nerve-locating anaesthesia needle
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