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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PS Vitamin E Insert Sz 2 08mm
Ortho Development Corporation
163-5208
In Commercial Distribution

  • 00822409040858 ()

  • Height: 8 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 2 07mm
Ortho Development Corporation
163-5207
In Commercial Distribution

  • 00822409040841 ()

  • Height: 7 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 1 20mm
Ortho Development Corporation
163-5120
In Commercial Distribution

  • 00822409040834 ()

  • Height: 20 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 1 18mm
Ortho Development Corporation
163-5118
In Commercial Distribution

  • 00822409040827 ()

  • Height: 18 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 1 16mm
Ortho Development Corporation
163-5116
In Commercial Distribution

  • 00822409040810 ()

  • Height: 16 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 1 14mm
Ortho Development Corporation
163-5114
In Commercial Distribution

  • 00822409040803 ()

  • Height: 14 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 1 13mm
Ortho Development Corporation
163-5113
In Commercial Distribution

  • 00822409040797 ()

  • Height: 13 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 1 12mm
Ortho Development Corporation
163-5112
In Commercial Distribution

  • 00822409040780 ()

  • Height: 12 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 1 11mm
Ortho Development Corporation
163-5111
In Commercial Distribution

  • 00822409040773 ()

  • Height: 11 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 1 10mm
Ortho Development Corporation
163-5110
In Commercial Distribution

  • 00822409040766 ()

  • Height: 10 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 1 09mm
Ortho Development Corporation
163-5109
In Commercial Distribution

  • 00822409040759 ()

  • Height: 9 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 1 08mm
Ortho Development Corporation
163-5108
In Commercial Distribution

  • 00822409040742 ()

  • Height: 8 Millimeter


  • Tibial insert
PS Vitamin E Insert Sz 1 07mm
Ortho Development Corporation
163-5107
In Commercial Distribution

  • 00822409040735 ()

  • Height: 7 Millimeter


  • Tibial insert
EXCAVATOR NO 20 SSW TYPE D/E
DARBY DENTAL SUPPLY, LLC
9512147
In Commercial Distribution

  • 00889813038543 ()
9512147

  • Dental excavator, reusable
EXCAVATOR NO 19 SSW TYPE D/E
DARBY DENTAL SUPPLY, LLC
9512146
In Commercial Distribution

  • 00889813038536 ()
9512146

  • Dental excavator, reusable
EXCAVATOR NO 18 SSW TYPE D/E
DARBY DENTAL SUPPLY, LLC
9512145
In Commercial Distribution

  • 00889813038529 ()
9512145

  • Dental excavator, reusable
EXCAVATOR NO 14 SSW TYPE D/E
DARBY DENTAL SUPPLY, LLC
9512142
In Commercial Distribution

  • 00889813038505 ()
9512142

  • Dental excavator, reusable
EXCAVATOR NO 5 SSW TYPE D/E
DARBY DENTAL SUPPLY, LLC
9512140
In Commercial Distribution

  • 00889813038499 ()
9512140

  • Dental excavator, reusable
Adjustable Spiked E/M Tibial Alignment Guide
Ortho Development Corporation
C-1737
In Commercial Distribution

  • 00822409111121 ()
C-1737

  • Osteotomy guide, reusable
MILLER BONE RASP; 7"(18CM), D/E
BLACK & BLACK SURGICAL, INC.
B63065
In Commercial Distribution

  • 00840329807672 ()
B63065

  • Bone file/rasp, manual, reusable
1-KNOB VIPR"E"CYL/2015 PSI/WHT
Western Enterprises
PRX-9646
In Commercial Distribution

  • B929PRX96460 ()
PRX-9646

  • Fixed medical gas cylinder regulator
INFINITY 1 KNOB"E"CYL 3000 PSI
Western Enterprises
MXS-903
Not in Commercial Distribution

  • B929MXS9030 ()
MXS-903

  • Fixed medical gas cylinder regulator
INFINITY 1 KNOB"E"CYL 2015 PSI
Western Enterprises
MXS-603
Not in Commercial Distribution

  • B929MXS6030 ()
MXS-603

  • Fixed medical gas cylinder regulator
HIV combi PT Elecsys cobas e 100
Roche Diagnostics GmbH
05390095160
In Commercial Distribution

  • 04015630942497 ()
05390095160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Ultra-Pro e™ Variable Angle Needle Guide
CIVCO MEDICAL INSTRUMENTS CO., INC.
610-1082
In Commercial Distribution

  • 00841436101943 ()
  • 10841436101940 ()

  • Needle Gauge: 16 Gauge
  • Length: 1.3 Inch
610-1082

  • Needle guide, single-use
e36O VENTILATOR, E MODEL CHINESE NA POWER
Covidien LP
E360E-CN-NA
In Commercial Distribution

  • 10884521540910 ()


  • Neonatal/adult intensive-care ventilator
EMILY E DR MEYER MW SINGLE SHO
MEDLINE INDUSTRIES, INC.
PAIN0245A
In Commercial Distribution

  • 40884389448411 ()
  • 10884389448410 ()
PAIN0245A

  • General surgical procedure kit, non-medicated, reusable
POZZI ORTHO CLEAR PURPLE LIQUID E 8OZ
AMERICAN TOOTH INDUSTRIES
041-RP6125-08
In Commercial Distribution

  • D772ATIRP6125080 ()


  • Dental acrylic resin
Gruber Ear Specula, Type E, Round, 4.0mm
Bear-Ent, LLC
6.05.15
In Commercial Distribution

  • G043605150 ()
6.05.15

  • Ear speculum, reusable
Gruber Ear Specula, Type E, Round, 2.0mm
Bear-Ent, LLC
6.05.13
In Commercial Distribution

  • G043605130 ()
6.05.13

  • Ear speculum, reusable
Gruber Ear Specula, Type E, Round, 5.0mm
Bear-Ent, LLC
6.05.16
In Commercial Distribution

  • G043605160 ()
6.05.16

  • Ear speculum, reusable
Gruber Ear Specula, Type E, Round, 3.0mm
Bear-Ent, LLC
6.05.14
In Commercial Distribution

  • G043605140 ()
6.05.14

  • Ear speculum, reusable
Tray Sleeve E 11 5/8 x16"
ICP, INC.
50-578
In Commercial Distribution

  • D771505780 ()
  • D77150578 ()


  • Medical equipment/instrument drape, single-use
E. coli O 18a O 18c : K77
PRO-LAB, INCORPORATED
PLA538
In Commercial Distribution

  • 00817978025382 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
Salmonella H: e,h For phase inversion
PRO-LAB, INCORPORATED
PLA235
In Commercial Distribution

  • 00817978022350 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
REFLECTION HA MULTI HOLE SHELL 50MM E
Smith & Nephew, Inc.
71335250
Not in Commercial Distribution

  • 03596010001481 ()
71335250

  • Acetabular shell
E/S ELECTRODE 90DG LHOOK 10/BX
Smith & Nephew, Inc.
7205441
In Commercial Distribution

  • 23596010252207 ()
  • 03596010252203 ()
7205441

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
LUER S-Shape Retractor D/E 11cm/4.5"
Anmuth Medical International, LLC
24-123-11
In Commercial Distribution

  • 08403207002372 ()

  • Length: 4.5 Inch
24-123-11

  • Hand-held surgical retractor, reusable
REFLECTION ACETABULAR SHELL MULTI-HOLE SIZE 52MM E
Smith & Nephew, Inc.
71335152
In Commercial Distribution

  • 03596010482440 ()
71335152

  • Acetabular shell
PLASMAFIT PRO 3 CUP SIZE 48MM E
Aesculap AG
NV848T
In Commercial Distribution

  • 04046964152283 ()

  • Outer diameter (mm) : 48.000 MM
  • Figure / Size : Fig. E
NV848T

  • Acetabular shell
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