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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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DeRoyal - 00749756627245

SYRINGE 10CC GREEN CA LAN 50C
DEROYAL INDUSTRIES, INC.
77-400598
In Commercial Distribution

  • 50749756627240 ()
  • 00749756627245 ()


  • Angiographic syringe

NA - 00763000927394

CUSTOM PACK BB11S99R15 CHICO CA 1
MEDTRONIC, INC.
BB11S99R15
In Commercial Distribution

  • 00763000927394 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000848446

CUSTOM PACK BB11S99R12 CHICO CA 1
MEDTRONIC, INC.
BB11S99R12
In Commercial Distribution

  • 00763000848446 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000845018

CUSTOM PACK BB11S99R11 CHICO CA 1
MEDTRONIC, INC.
BB11S99R11
In Commercial Distribution

  • 00763000845018 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000630225

CUSTOM PACK BB11S99R2 CHICO CA 1
MEDTRONIC, INC.
BB11S99R2
In Commercial Distribution

  • 00763000630225 ()


  • Cardiopulmonary bypass system blood tubing set

AccuThrive® - 00843382104054

AccuThrive Longevity Microtome Blade Low Profile SS Microcoat 100BL/CA (10BL/DISP, 10 DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104051 ()
  • 00843382104054 ()
AVBL-2010-0000

  • Microtome blade IVD, single-use

AccuThrive® - 00843382104023

AccuThrive Agility Microtome Blade Low Profile SS Microcoat 100BL/CA (10BL/DISP 10 DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104020 ()
  • 00843382104023 ()
AVBL-2006-0000

  • Microtome blade IVD, single-use

AccuThrive® - 00843382104016

AccuThrive Agility Microtome Blade High Profile SS Microcoat 500BL/CA (50BL/DISP 10 DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104013 ()
  • 00843382104016 ()
AVBL-2005-0000

  • Microtome blade IVD, single-use

AccuThrive® - 00843382104009

AccuThrive Agility Microtome Blade Low Profile SS Microcoat 500BL/CA (50BL/DISP 10 DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104006 ()
  • 00843382104009 ()
AVBL-2007-0000

  • Microtome blade IVD, single-use

iCE Surgical Light - 00684706007091

S1 200DT Triple CA 1300 1150 1000 CA 2x LCH 3P SL-30M, 1x Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007091 ()
C12T543441

  • Operating room light

iCE Surgical Light - 00684706001082

S3 300 DT Sgl CA Dual CA 1300 1150 1000 9P DY 30M 2xMH Gen2
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001082 ()
C33SDB543151

  • Operating room light

iCE Surgical Light - 00684706001075

S3 300 DT Sgl CA Dual CA 1300 1150 1000 3P DY 30M 2xMH Gen2
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001075 ()
C33SDB543131

  • Operating room light

iCE Surgical Light - 00684706001914

S3 300DT 2x Sgl CA 1xdual CA 2x 1150, 1x1000,1x850, 2xsgl MH 1x3P 1x9P SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001914 ()
C33SDS43241351

  • Operating room light

iCE Surgical Light - 00684706001587

S3 400DT 2x Sgl CA 1xdual CA 2x 1150, 1x1000,1x850, 2xsgl MH 1x3P 1x9P SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001587 ()
C34SDS43241351

  • Operating room light

PETROLATUM GAUZE® - 10381780491750

Petrolatum Gauze Non-Adhering Dressing
Derma Sciences Canada Inc
20065
In Commercial Distribution

  • 30381780491754 ()
  • 10381780491750 ()

  • 15.2 com X 91.4 cm
  • 6 in X 36 in
DKC20065

  • Petrolatum woven gauze pad

OrthoFlex - 00190730002341

OrtFlx Com McLaughlin 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-841
In Commercial Distribution

  • 00190730002341 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002303

OrtFlx Com McLaughlin 022 U4/5 Rx -7º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-830
In Commercial Distribution

  • 00190730002303 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001962

OrtFlx Com McLaughlin 018 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-741
In Commercial Distribution

  • 00190730001962 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001924

OrtFlx Com McLaughlin 018 U4/5 Rx -7º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-730
In Commercial Distribution

  • 00190730001924 ()


  • Orthodontic bracket, plastic, single-use

Avalon - 00190730000644

Avalon Com Roth 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A22-841
In Commercial Distribution

  • 00190730000644 ()


  • Orthodontic bracket, plastic, single-use

Avalon - 00190730000460

Avalon Com Roth 018 L1/2 Rx -6° Tor. 0° Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A18-741
Not in Commercial Distribution

  • 00190730000460 ()


  • Orthodontic bracket, plastic, single-use

Gimmi - 04049047694526

COLLIN RIB SHEAR LENGTH 195 MM
Gimmi GmbH
CA.1104.22
In Commercial Distribution

  • 04049047694526 ()
CA.1104.22

  • Bone cutting forceps, reusable

Gimmi - 04049047176220

BETHUNE RIB SHEAR HANDLES WITH RUBBER COVER LENGTH 340 MM
Gimmi GmbH
CA.1153.34
In Commercial Distribution

  • 04049047176220 ()
CA.1153.34

  • Bone cutting forceps, reusable

Gimmi - 04049047031680

BRUNNER RIB SHEAR LENGTH 320 MM
Gimmi GmbH
CA.1152.28
In Commercial Distribution

  • 04049047031680 ()
CA.1152.28

  • Bone cutting forceps, reusable

Gimmi - 04049047031666

GIERTZ-STILLE RIB SHEAR LENGTH 270 MM
Gimmi GmbH
CA.1140.27
In Commercial Distribution

  • 04049047031666 ()
CA.1140.27

  • Bone cutting forceps, reusable

Gimmi - 04049047031628

RIB SHEAR LENGTH 220 MM
Gimmi GmbH
CA.1104.22
In Commercial Distribution

  • 04049047031628 ()
CA.1104.22

  • Bone cutting forceps, reusable

Gimmi - 04049047031697

LEBSCHE STERNUM CHISEL LENGTH 245 MM
Gimmi GmbH
CA.1154.24
In Commercial Distribution

  • 04049047031697 ()
CA.1154.24

  • Orthopaedic chisel

IMS - 10889950070731

INFINITY OS CASS,PURPLE,E7,C4,C2 ACC,AW2
HU-FRIEDY MFG. CO., LLC
IMNOS4E/CA
In Commercial Distribution

  • 10889950070731 ()
IMNOS4E/CA

  • Device sterilization/disinfection container, reusable

Intervertebral Body Fusion Device - 00840019923910

PLIF Tray
PRECISION SPINE, INC.
21-1001 CA
In Commercial Distribution

  • 00840019923910 ()
21-1001 CA

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019923897

TPLIF Tray/TLIF Tray
PRECISION SPINE, INC.
21-1002 CA
In Commercial Distribution

  • 00840019923897 ()
21-1002 CA

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019923873

TPLIF/TLIF Instrument Tray
PRECISION SPINE, INC.
21-1008 CA
In Commercial Distribution

  • 00840019923873 ()
21-1008 CA

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019923866

TLIF/ PLIF/ TPLIF system
PRECISION SPINE, INC.
21-1007 CA
In Commercial Distribution

  • 00840019923866 ()
21-1007 CA

  • Orthopaedic surgical procedure kit, non-medicated, reusable

TSI/ERI Custom Abutment - D7854CATA0

Transmucosal Abutment 4mm & 5mm Diameter
OCO BIOMEDICAL INC
TSI/ERI Transmucosal Abutment 4mm & 5mm
In Commercial Distribution

  • D7854CATA0 ()
4.0 CA

  • Dental implant system

TSI/ERI Custom Abutment - D785325CATA0

TSI/ERI Transmucosal Abutment 3.25mm 3.25mm Diameter
OCO BIOMEDICAL INC
TSI/ERI Transmucosal Abutment 3.25mm
In Commercial Distribution

  • D785325CATA0 ()
3.25 CA

  • Dental implant suprastructure, permanent, preformed

ASSISTO® Arm-System - 14049679076803

ASSISTO R310MM W DETACHABLE U-STAND
GEOMED Medizin-Technik GmbH & Co. KG
CA 305-22-01
In Commercial Distribution

  • 14049679076803 ()
CA 305-22-01

  • Surgical instrument assist arm system, manually-adjusted

ASSISTO® Arm-System - 14049679076735

ASSISTO R310MM U-STAND 400X400X170MM WITH UNIVERSAL RETRACTOR HOLDER
GEOMED Medizin-Technik GmbH & Co. KG
CA 301-20-01
In Commercial Distribution

  • 14049679076735 ()
CA 301-20-01

  • Surgical instrument assist arm system, manually-adjusted

ASSISTO® Arm-System - 14049679076681

ASSISTO R310MM L-STAND 134X170MM WITH UNIVERSAL RETRACTOR HOLDER
GEOMED Medizin-Technik GmbH & Co. KG
CA 235-30-01
In Commercial Distribution

  • 14049679076681 ()
CA 235-30-01

  • Surgical instrument assist arm system, manually-adjusted

Curaplex - 00810071637292

HIGH FLOW START KIT,7'*,10/CA
BOUND TREE MEDICAL, LLC
P3052EA
In Commercial Distribution

  • 00810071638015 ()
  • 00810071637292 ()
301-P3052EA

  • Non-heated respiratory humidifier

Insulin Syringes - 50382903247023

SYRINGE 0.3ML 29GA 1/2IN 200BX CA
BECTON, DICKINSON AND COMPANY
324702
Not in Commercial Distribution

  • 10382903247025 ()
  • 50382903247023 ()
  • 80382903247024 ()

  • Needle Gauge: 29 Gauge
  • Length: 12.77 Millimeter
324702

  • Insulin syringe/needle, basic

Curaplex - 00810071631283

MASK,TRACH,ADULT,CURAPLEX,SPU,50/CA
BOUND TREE MEDICAL, LLC
301-184
In Commercial Distribution

  • 00810071630880 ()
  • 00810071631283 ()
301-184

  • Tracheostomy mask, oxygen

Curaplex - 00810071631160

TEE,AEROSOL,22MX22MX15F 50/BG 100/CA
BOUND TREE MEDICAL, LLC
301-160EA
In Commercial Distribution

  • 00810071630767 ()
  • 00810071631160 ()
301-160EA

  • Non-rebreathing valve, single-use

Ventlab - 30889483271036

PVC Anesthesia Mask #2, Pediatric, 150/CA
VENTLAB, LLC
812-0007-01
Not in Commercial Distribution

  • 30889483271036 ()
812-0007-01

  • Anaesthesia face mask, single-use

Ventlab - 30889483271012

PVC Anesthesia Mask #1, Infant, 200/CA
VENTLAB, LLC
812-0006-01
In Commercial Distribution

  • 30889483271012 ()
812-0006-01

  • Anaesthesia face mask, single-use

Rabbit Monoclonal Anti-Human CA 125 Antibody, EP48 - 00810113061405

Rabbit Monoclonal Anti-Human CA 125 (48), concentrated
Epitomics Inc.
AC-0046BULK
In Commercial Distribution

  • 00810113061405 ()


  • Cancer antigen 125 (CA125) IVD, antibody

PHONAK - 07613389356014

KS 9.0 Kit Monaural CA (velvet black)
Sonova AG
051-0115-P856
In Commercial Distribution

  • 07613389356014 ()
051-0115-P856

  • Air-conduction hearing aid, receiver-in-canal

PHONAK - 07613389356007

KS 9.0 Kit Monaural CA (silver gray)
Sonova AG
051-0115-P656
In Commercial Distribution

  • 07613389356007 ()
051-0115-P656

  • Air-conduction hearing aid, receiver-in-canal

PHONAK - 07613389356540

KS 9.0 T Kit Monaural CA (beige)
Sonova AG
051-0159-H056
In Commercial Distribution

  • 07613389356540 ()
051-0159-H056

  • Air-conduction hearing aid, behind-the-ear

PHONAK - 07613389356533

KS 9.0 T Kit Monaural CA (stone)
Sonova AG
051-0159-D056
In Commercial Distribution

  • 07613389356533 ()
051-0159-D056

  • Air-conduction hearing aid, behind-the-ear

Henry Schein - 10304040167387

PACK FACE LIFT EENT F/ CA CUSTOM
HENRY SCHEIN, INC.
5703230
In Commercial Distribution

  • 00304040167380 ()
  • 10304040167387 ()
5703230

  • General surgical procedure kit, non-medicated, single-use

Henry Schein - 10304040166953

PACK PATIENT F/ UNIV S CA CUSTOM
HENRY SCHEIN, INC.
5703239
In Commercial Distribution

  • 00304040166956 ()
  • 10304040166953 ()
5703239

  • General surgical procedure kit, non-medicated, single-use
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