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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The depth gauge is used by the surgeon to choose the length of the screw or the staple to implant.
NEWDEAL
997301ND
In Commercial Distribution

  • M248997301ND1 ()
  • 10381780044888 ()


  • Surgical depth gauge, reusable
Instrument used to screw the “screw-washer” assembly to the cap, locking the tendon against the locking corridor of the cap.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739164 ()
  • 28437019739168 ()


  • Surgical screwdriver, reusable
The Woodpecker is a pneumatically powered device whereby the surgeon can create a precisely reamed prosthesis bed in the medullary femur. The minimal impulses generated by the rasp machine reduce tension peaks, fissures and splintering. The low intraosseous pressure minimizes the risk of fat embolism syndrome substantially. The high-frequency axial impulses of the instrument substantially reduce operating time.
IMT Integral Medizintechnik AG
The Woodpecker
In Commercial Distribution

  • 07629999033979 ()


  • Bone/joint surgical power tool motorized handpiece/set, pneumatic
THE TOPPER REPLACEABLE ZIP OFF OUTER LAYER 84 X 48
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933RMEM8448 ()
R-MEM8448

  • Low-air-loss bed
THE TOPPER REPLACEABLE ZIP OFF OUTER LAYER 84 X 42
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933RMEM8442 ()
R-MEM8442

  • Low-air-loss bed
THE TOPPER REPLACEABLE ZIP OFF OUTER LAYER 84 X 36
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933RMEM8436 ()
R-MEM8436

  • Low-air-loss bed
MEM 84 X 48 W/COVERLET AND CONTROL UNIT
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933RDMEM8448 ()
RDMEM8448

  • Low-air-loss bed
MEM 84 X 42 W/COVERLET AND CONTROL UNIT
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933RDMEM8442 ()
RDMEM8442

  • Low-air-loss bed
MEM 84 X 60 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM8460CEI0 ()
MEM8460CEI

  • Alternating-pressure inflator
MEM 84 X 60 W/COVERLET AND CONTROL UNIT
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM8460 ()
MEM8460

  • Low-air-loss bed
MEM 84 X 48 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM8448CEI0 ()
MEM8448CEI

  • Alternating-pressure inflator
MEM 84 X 48 W/COVERLET AND CONTROL UNIT
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM8448 ()
MEM8448

  • Low-air-loss bed
MEM 84 X 42 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM8442CEI0 ()
MEM8442CEI

  • Alternating-pressure inflator
MEM 84 X 42 W/COVERLET AND CONTROL UNIT
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM8442 ()
MEM8442

  • Low-air-loss bed
MEM 84 X 36 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM8436CEI0 ()
MEM8436CEI

  • Alternating-pressure inflator
MEM 80 X 60 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM8060CEI0 ()
MEM8060CEI

  • Alternating-pressure inflator
MEM 80 X 60 W/COVERLET AND CONTROL UNIT
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM8060 ()
MEM8060

  • Low-air-loss bed
MEM 80 X 54 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM8054CEI0 ()


  • Alternating-pressure inflator
MEM 80 X 54 W/COVERLET AND CONTROL UNIT
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM8054 ()
MEM8054

  • Low-air-loss bed
MEM 75 X 54 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM7554CEI0 ()
MEM7554CEI

  • Alternating-pressure inflator
MEM 75 X 54 W/COVERLET AND CONTROL UNIT
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM7554 ()
MEM7554

  • Low-air-loss bed
MEM 80 X 48 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM48CEI0 ()
MEM48CEI

  • Alternating-pressure inflator
MEM 80 X 48 W/COVERLET AND CONTROL UNIT
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM48 ()
MEM48

  • Low-air-loss bed
MEM 80 X 42 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM42CEI0 ()
MEM42CEI

  • Alternating-pressure inflator
MEM 80 X 42 W/COVERLET AND CONTROL UNIT
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM42 ()
MEM42

  • Low-air-loss bed
MEM 80 X 36 W/COVERLET AND CONTROL UNIT AUSTRALIA
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H933MEM36CEI0 ()
MEM36CEI

  • Alternating-pressure inflator
MEM 80 X 36 W/COVERLET AND CE CONTROL UNIT
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H93377741 ()
77741

  • Low-air-loss bed
MEM PUMP
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H9332100X0 ()
2100X

  • Alternating-pressure inflator
MEM PUMP CEG
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H9332100CEG0 ()
2100CEG

  • Alternating-pressure inflator
MEM PUMP CEC
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H9332100CEC0 ()
2100CEC

  • Alternating-pressure inflator
MEM PUMP
SPAN-AMERICA MEDICAL SYSTEMS, INC.
The Topper
In Commercial Distribution

  • H9332100 ()
2100

  • Alternating-pressure inflator
Radio Frequency Therapy System
WONTECH CO.,LTD
The Oligio
In Commercial Distribution

  • 08800022305310 ()


  • Radio-frequency skin contouring system
Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Naturalcycles Nordic AB
13
In Commercial Distribution

  • 07350014630131 ()


  • Self-care monitoring/reporting software
Pole to assist the patient to raise the body from Hospital Bed
PARAMOUNT BED CO., LTD.
PC-5111
In Commercial Distribution

  • 04527799701582 ()


  • Assistive patient lifting pole
Pole to assist the patient to raise the body from Hospital Bed.
PARAMOUNT BED CO., LTD.
KA-H70LU
In Commercial Distribution

  • 04527799700271 ()


  • Assistive patient lifting pole
Device to retract the lips/cheeks to facilitate viewing of the teeth.
STRAIGHT SMILE LLC
BSS1
In Commercial Distribution

  • 00850017524002 ()


  • Dental cheek retractor, home-use
FINECROSS MG Coronary Micro-Guide Catheter
TERUMO CORPORATION
35-1450
In Commercial Distribution

  • 54987350703182 ()
  • 04987350703187 ()

  • Outer Diameter: 0.60 Millimeter
  • Length: 150 Centimeter
  • Clinically Relevant Size 1 is relative to the catheter distal end. And Clinically Relevant Size 2 is relative to the catheter proximal shaft.
NC*F865A

  • Vascular guide-catheter, single-use
FINECROSS MG Coronary Micro-Guide Catheter
TERUMO CORPORATION
35-1430
In Commercial Distribution

  • 54987350703168 ()
  • 04987350703163 ()

  • Outer Diameter: 0.60 Millimeter
  • Clinically Relevant Size 1 is relative to the catheter distal end. And Clinically Relevant Size 2 is relative to the catheter proximal shaft.
  • Length: 130 Centimeter
NC*F863A

  • Vascular guide-catheter, single-use
The R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.
SUNRISE MEDICAL (US) LLC
R90
In Commercial Distribution

  • 00016958059465 ()
EISP8

  • Wheelchair electric-motor-driven propulsion system
Biopsy Tray
ROBERT BUSSE & CO., INC.
2002
In Commercial Distribution

  • 10849233006871 ()
  • 00849233006874 ()


  • General surgical procedure kit, non-medicated, single-use
The Roth Net retriever select is used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711169
Not in Commercial Distribution

  • 10816765013509 ()
  • 00816765013502 ()

  • Width: 3 Centimeter
  • Length: 230 Centimeter
  • Outer Diameter: 2.5 Millimeter
00711169

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The disposable Raptor grasping device-mini is be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
US Endoscopy
00711178
Not in Commercial Distribution

  • 10816765012564 ()
  • 00816765012567 ()

  • Outer Diameter: 1.9 Millimeter
  • Length: 200 Centimeter
00711178

  • Flexible endoscopic tissue manipulation forceps, single-use
The disposable Raptor grasping device-mini is be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
US Endoscopy
00711178
In Commercial Distribution

  • 10724995183667 ()
  • 00724995183660 ()
  • 00816765012567 ()

  • Length: 200 Centimeter
  • Outer Diameter: 1.9 Millimeter
00711178

  • Flexible endoscopic tissue manipulation forceps, single-use
The Roth Net retriever select is used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711169
In Commercial Distribution

  • 10724995182769 ()
  • 00724995182762 ()
  • 00816765013502 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 230 Centimeter
  • Width: 3 Centimeter
00711169

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The Lance Pilot Drill is used to penetrate the cortical bone in order to mark the site and to guide the subsequent drills.
STERNGOLD DENTAL LLC
903014
In Commercial Distribution

  • 00841549110092 ()


  • Fixture/appliance dental drill bit, reusable
OXIMETER,PULSE,FINGER,BLUETOOTH WITH APP
MEDLINE INDUSTRIES, INC.
HCSM70T
In Commercial Distribution

  • 00193489094261 ()
HCSM70T

  • Vacuum suction regulator/regulation set, general-purpose
Cochlear Baha Control App for Android
Cochlear Bone Anchored Solutions AB
95460
In Commercial Distribution

  • 09321502036399 ()
95460

  • Hearing aid/implant system remote control
Cochlear Baha Control App for iOS
Cochlear Bone Anchored Solutions AB
95459
In Commercial Distribution

  • 09321502036382 ()
95459

  • Hearing aid/implant system remote control
IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2325
In Commercial Distribution

  • 20193489194811 ()
  • 10193489194814 ()
DYNDV2325

  • Peripheral intravenous catheterization support kit
MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
In Commercial Distribution

  • 04953170355981 ()


  • Surgical instrument assist arm system, manually-adjusted
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