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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HOWARTH ELEV D/E 8 1/2 INCHES
SKLAR CORPORATION
40-8260
In Commercial Distribution

  • 10649111326899 ()


  • Neurosurgical bone flap elevator
E. coli O 112a O 112c : K 66
PRO-LAB, INCORPORATED
PLA541
In Commercial Distribution

  • 00817978025412 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
E. coli O 20a O 20b : K 84
PRO-LAB, INCORPORATED
PLA539
In Commercial Distribution

  • 00817978025399 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
Salmonella H: e,n,z_15 For phase inversion
PRO-LAB, INCORPORATED
PLA237
In Commercial Distribution

  • 00817978022374 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
Salmonella H: e,n,x For phase inversion
PRO-LAB, INCORPORATED
PLA236
In Commercial Distribution

  • 00817978022367 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
Patella, UHMWPE with Vitamin E, 39mm x 11mm
OPTIMOTION IMPLANTS LLC
1014-P-3911
In Commercial Distribution

  • B6961014P39110 ()


  • Cruciate-retaining total knee prosthesis
Patella, UHMWPE with Vitamin E, 36mm x 10mm
OPTIMOTION IMPLANTS LLC
1014-P-3610
In Commercial Distribution

  • B6961014P36100 ()


  • Cruciate-retaining total knee prosthesis
Patella, UHMWPE with Vitamin E, 33mm x 9mm
OPTIMOTION IMPLANTS LLC
1014-P-3309
In Commercial Distribution

  • B6961014P33090 ()


  • Cruciate-retaining total knee prosthesis
Patella, UHMWPE with Vitamin E, 31mm x 9mm
OPTIMOTION IMPLANTS LLC
1014-P-3109
In Commercial Distribution

  • B6961014P31090 ()


  • Cruciate-retaining total knee prosthesis
Patella, UHMWPE with Vitamin E, 29mm x 8mm
OPTIMOTION IMPLANTS LLC
1014-P-2908
In Commercial Distribution

  • B6961014P29080 ()


  • Cruciate-retaining total knee prosthesis
Patella, UHMWPE with Vitamin E, 27mm x 8mm
OPTIMOTION IMPLANTS LLC
1014-P-2708
In Commercial Distribution

  • B6961014P27080 ()


  • Cruciate-retaining total knee prosthesis
CODMAN® HOLTER® Atrial Catheter Type "E"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
821676
In Commercial Distribution

  • 10381780518006 ()
82-1676

  • Atrial cerebrospinal fluid catheter
POZZI ORTHO CLEAR PURPLE LIQUID E 4 OZ
AMERICAN TOOTH INDUSTRIES
041-RP6135-04
In Commercial Distribution

  • D772ATIRP6135040 ()


  • Dental acrylic resin
POZZI ORTHO CLEAR PURPLE LIQUID E 1 OZ
AMERICAN TOOTH INDUSTRIES
041-RP6125-01
In Commercial Distribution

  • D772ATIRP6125010 ()


  • Dental acrylic resin
S E MAYO DISS SCISS CVD 9 TC
SKLAR CORPORATION
16-1615
In Commercial Distribution

  • 10649111379086 ()


  • General-purpose surgical scissors, reusable
S E MAYO DIS SCISS STR 9 TC
SKLAR CORPORATION
16-1515
In Commercial Distribution

  • 10649111364952 ()


  • General-purpose surgical scissors, reusable
CENSITRAC READY COTTLE ELEV CM-GRAD D/E 9
SKLAR CORPORATION
41-1235C
In Commercial Distribution

  • 10649111398988 ()


  • Bone lever/elevator, reusable
CENSITRAC READY CURETTE EXCA D/E 1-3 1.5X2.5MM
SKLAR CORPORATION
97-0536C
In Commercial Distribution

  • 10649111397561 ()


  • General-purpose curette
CENSITRAC READY CURETTE EXCA D/E 1-2 1.5X2MM
SKLAR CORPORATION
97-0532C
In Commercial Distribution

  • 10649111397554 ()


  • General-purpose curette
REFLECTION ACETABULAR SHELL MULTI-HOLE SIZE 50MM SIZE E
Smith & Nephew, Inc.
71335150
In Commercial Distribution

  • 03596010000781 ()
71335150

  • Acetabular shell
correct brand name is TEE122 with two E
ESAOTE SPA
9600186000
In Commercial Distribution

  • 08056304452191 ()


  • Oesophageal ultrasound imaging transducer, reusable
.022 LR7 Mini Buccal Tube Tempra / Cleat (E)
ORTHO ORGANIZERS, INC.
950-153091E
In Commercial Distribution

  • 00190707075842 ()


  • Orthodontic metal band
.022 LR7 Mini Buccal Tube Epic -12T (E)
ORTHO ORGANIZERS, INC.
950-15507E
In Commercial Distribution

  • 00190707075828 ()


  • Orthodontic metal band
.022 LL7 Mini Buccal Tube Tempra / Cleat (E)
ORTHO ORGANIZERS, INC.
950-154091E
In Commercial Distribution

  • 00190707075798 ()


  • Orthodontic metal band
.022 LL7 Mini Buccal Tube Epic -12T (E)
ORTHO ORGANIZERS, INC.
950-15607E
In Commercial Distribution

  • 00190707075774 ()


  • Orthodontic metal band
.018 Elite® UL6 Single Buccal Tube (E)
ORTHO ORGANIZERS, INC.
900-00808E
In Commercial Distribution

  • 00190707073251 ()


  • Orthodontic metal band
CIRCUIT, UNHTD, DL, W/ E VALVE, PMT, 72"
MEDLINE INDUSTRIES, INC.
HUD1627
In Commercial Distribution

  • 20197344012289 ()
  • 10197344012282 ()
HUD1627

  • Ventilator breathing circuit, single-use
TiNbN Coated Femoral PCK Stemmed, Size E, Right
MAXX ORTHOPEDICS, INC.
RFPSRE00-GK
In Commercial Distribution

  • 00810008128503 ()


  • Uncoated knee tibia prosthesis, polyethylene
TiNbN Coated Femoral PCK Stemmed, Size E, Left
MAXX ORTHOPEDICS, INC.
RFPSLE00-GK
In Commercial Distribution

  • 00810008128442 ()


  • Uncoated knee tibia prosthesis, polyethylene
CUSTOM PACK CB10Z55R1 E C 1/4W/BRID
MEDTRONIC, INC.
CB10Z55R1
In Commercial Distribution

  • 00763000273644 ()


  • Cardiopulmonary bypass system blood tubing set
LIFESTYLES LIQUID PERSONAL LUBRICANT ALOE & VITAMIN E 4.5g
SURETEX LIMITED - BRANCH
7000
In Commercial Distribution

  • 30070907070001 ()
  • 80070907321627 ()


  • Sexual lubricant
CENSITRAC READY ROUX D/E RETRACTORS SET/3
SKLAR CORPORATION
60-1100C
In Commercial Distribution

  • 30649111391020 ()
  • 00649111391029 ()


  • Hand-held surgical retractor, reusable
Feeding Set 30cm E. Set Universal & straight conn.
DEGANIA SILICONE LTD
1032230080AQ
In Commercial Distribution

  • 27290001609785 ()
  • 07290001609781 ()
  • 47290001609789 ()


  • Enteral tube extension, single-use
9 E Det Rongeur Lumbar 40 Up 6Mm
SYMMETRY SURGICAL INC.
531654LED
Not in Commercial Distribution

  • 00887482033616 ()
531654LED

  • Spinal rongeur
CUSTOM PACK CB10Z55R2 E C 1/4W/BRID
MEDTRONIC, INC.
CB10Z55R2
In Commercial Distribution

  • 00763000505448 ()


  • Cardiopulmonary bypass system blood tubing set
RESVOR 22101 E NEONATE FLAT DOME IC 20MM
MEDTRONIC PS MEDICAL, INC.
22101 E
In Commercial Distribution

  • 00763000030421 ()


  • Cranial port/reservoir
CATH 5005 E VENT RT ANGLE STD 5CM
MEDTRONIC PS MEDICAL, INC.
5005 E
In Commercial Distribution

  • 00763000029494 ()


  • Intracerebral infusion/drainage catheter, long-term
CUSTOM PACK BB11S47R2 E C L S LINE
MEDTRONIC, INC.
BB11S47R2
In Commercial Distribution

  • 00763000829469 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB12E92R3 E C L S PK
MEDTRONIC, INC.
CB12E92R3
In Commercial Distribution

  • 00763000936518 ()


  • Cardiopulmonary bypass system blood tubing set
Endo-Express E Type Mini Latch Head Contra Angle
ESSENTIAL DENTAL SYSTEMS, INC.
5520-00
Not in Commercial Distribution

  • 00766054001218 ()
5520-00

  • Dental power tool handpiece motorless component
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