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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Tryon (Logical) Liner, Constrained Assembly E
ORTHOMEDFLEX LLC
111129204
In Commercial Distribution

  • M7161111292040 ()
111-12-9204

  • Constrained polyethylene acetabular liner
Cyclin E Protein, Clone HE12, 10mL
Slmp, LLC
(BTO) Cyclin E Protein (HE12) Antibody (10ml)
In Commercial Distribution

  • 00810170551079 ()
MM44-10

  • Cyclin E1 IVD, antibody
E P S LAB SURGERY PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ55346J
In Commercial Distribution

  • 40198459266011 ()
  • 10198459266010 ()
DYNJ55346J

  • General surgical procedure kit, non-medicated, single-use
HSB - Burnisher D/E #27/29
Frontier Dental Supply Inc
HSB-300263
In Commercial Distribution

  • 00810132803727 ()


  • Manual dental burnisher, reusable
HSB - Scaler D/E #S5/33
Frontier Dental Supply Inc
HSB-300196
In Commercial Distribution

  • 00810132803079 ()


  • Manual dental scaler, reusable
HSB - Burnisher D/E #21B Acorn
Frontier Dental Supply Inc
HSB-300115
In Commercial Distribution

  • 00810132802324 ()


  • Manual dental burnisher, reusable
CUSTOM PACK BB11U53R1 E HEART L
MEDTRONIC, INC.
BB11U53R1
In Commercial Distribution

  • 00763000959821 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB12F51R2 E ASSIST PACK
MEDTRONIC, INC.
BB12F51R2
In Commercial Distribution

  • 00763000953423 ()


  • Cardiopulmonary bypass system blood tubing set
Femoral Provisional Size E RM/LL
Smith & Nephew, Inc.
00584101502
In Commercial Distribution

  • 00885556619278 ()
00584101502

  • Knee femur prosthesis trial, reusable
Femoral Provisional Size E LM/RL
Smith & Nephew, Inc.
00584101501
In Commercial Distribution

  • 00885556619261 ()
00584101501

  • Knee femur prosthesis trial, reusable
Stride Insert Trial Size E 11mm
Smith & Nephew, Inc.
PFSR101013
In Commercial Distribution

  • 00885556627839 ()
PFSR101013

  • Knee tibia prosthesis trial, reusable
Stride Insert Trial Size E 10mm
Smith & Nephew, Inc.
PFSR101012
In Commercial Distribution

  • 00885556627822 ()
PFSR101012

  • Knee tibia prosthesis trial, reusable
Stride Insert Trial Size E 9mm
Smith & Nephew, Inc.
PFSR101011
In Commercial Distribution

  • 00885556627815 ()
PFSR101011

  • Knee tibia prosthesis trial, reusable
Stride Insert Trial Size E 8mm
Smith & Nephew, Inc.
PFSR101010
In Commercial Distribution

  • 00885556627808 ()
PFSR101010

  • Knee tibia prosthesis trial, reusable
Stride Poly Insert Size E 11mm
Smith & Nephew, Inc.
PFSI00048
In Commercial Distribution

  • 00885556627082 ()
PFSI00048

  • Unicondylar knee insert
Stride Poly Insert Size E 10mm
Smith & Nephew, Inc.
PFSI00047
In Commercial Distribution

  • 00885556627075 ()
PFSI00047

  • Unicondylar knee insert
Stride Poly Insert Size E 9mm
Smith & Nephew, Inc.
PFSI00046
In Commercial Distribution

  • 00885556627068 ()
PFSI00046

  • Unicondylar knee insert
Stride Poly Insert Size E 8mm
Smith & Nephew, Inc.
PFSI00045
In Commercial Distribution

  • 00885556627051 ()
PFSI00045

  • Unicondylar knee insert
CURETTE EXCA D/E 1-3 1.5X2.5MM
SKLAR CORPORATION
21-190
In Commercial Distribution

  • 40649111398781 ()
  • 00649111398783 ()


  • Endaural surgical curette, single-use
E. coli Suspension [1cc vial - each]
Scientific Device Laboratory, Inc.
452
In Commercial Distribution

  • 00810047421955 ()


  • General microbial isolate identification control IVD
100SH 35X35-14X14 E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
In Commercial Distribution

  • 60889976046593 ()
  • 40889976046599 ()
  • 00889976046591 ()
6046593

  • Medical x-ray film, screen
100SH 11X14IN E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976046005 ()
  • 40889976046001 ()
  • 00889976046003 ()
6046007

  • Medical x-ray film, screen
100SH 10X12IN E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
In Commercial Distribution

  • 60889976045992 ()
  • 40889976045998 ()
  • 00889976045990 ()
6045991

  • Medical x-ray film, screen
100SH 8X10IN E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
In Commercial Distribution

  • 60889976045985 ()
  • 40889976045981 ()
  • 00889976045983 ()
6045983

  • Medical x-ray film, screen
100SH 18X24CM E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
In Commercial Distribution

  • 60889976045947 ()
  • 40889976045943 ()
  • 00889976045945 ()
6045942

  • Medical x-ray film, screen
100SH 24X30CM E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045930 ()
  • 40889976045936 ()
  • 00889976045938 ()
6045934

  • Medical x-ray film, screen
100SH 30X35CM E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
In Commercial Distribution

  • 60889976045923 ()
  • 40889976045929 ()
  • 00889976045921 ()
6045926

  • Medical x-ray film, screen
100SH 8X10IN E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045909 ()
  • 40889976045905 ()
  • 00889976045907 ()
6045900

  • Medical x-ray film, screen
100SH 10X12IN E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
In Commercial Distribution

  • 60889976045893 ()
  • 40889976045899 ()
  • 00889976045891 ()
6045892

  • Medical x-ray film, screen
100SH 11X14IN E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045886 ()
  • 40889976045882 ()
  • 00889976045884 ()
6045884

  • Medical x-ray film, screen
100SH 18X43-7X17 E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
In Commercial Distribution

  • 60889976045626 ()
  • 40889976045622 ()
  • 00889976045624 ()
6045629

  • Medical x-ray film, screen
100SH 35X43-14X17 E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045619 ()
  • 40889976045615 ()
  • 00889976045617 ()
6045611

  • Medical x-ray film, screen
100SH 35X35-14X14 E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045602 ()
  • 40889976045608 ()
  • 00889976045600 ()
6045603

  • Medical x-ray film, screen
100SH 30X40CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045596 ()
  • 40889976045592 ()
  • 00889976045594 ()
6045595

  • Medical x-ray film, screen
100SH 24X30CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045589 ()
  • 40889976045585 ()
  • 00889976045587 ()
6045587

  • Medical x-ray film, screen
100SH 20X40CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045572 ()
  • 40889976045578 ()
  • 00889976045570 ()
6045579

  • Medical x-ray film, screen
100SH 18X24CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045565 ()
  • 40889976045561 ()
  • 00889976045563 ()
6045561

  • Medical x-ray film, screen
100SH 15X40CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045558 ()
  • 40889976045554 ()
  • 00889976045556 ()
6045553

  • Medical x-ray film, screen
100SH 13X18CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
In Commercial Distribution

  • 60889976045534 ()
  • 40889976045530 ()
  • 00889976045532 ()
6045538

  • Medical x-ray film, screen
Lead Locking Device (LLD™ E)
Spectranetics Corporation
518-039AA
In Commercial Distribution

  • 00813132020828 ()
  • M204518039AA0 ()
  • 20813132020822 ()
518-039

  • Pacing/defibrillation lead stylet, extraction
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