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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KIATO PLUS Sterile Stainless Steel Surgical Blade box of 100 size 10. Sterilized by Gamma Irradiation
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895181108 ()
  • 08902895181104 ()
18189

  • Manual scalpel blade, single-use
Kiato Sterile Disposable scalpel Stainless Steel box of 10 size 10. Sterilized using ethylene oxide.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895148101 ()
  • 08902895148107 ()
14810

  • Scalpel, single-use
KIATO Plus Sterile Safety Scalpel Stainless Steel Box of 10 size 10. Sterilized using ethylene oxide.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895129100 ()
  • 08902895129106 ()
12910

  • Scalpel, single-use
KIATO Sterile CE carbon Steel Surgical Blade Box of 100 size 10. Sterilized by Gamma Irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 08902895111101 ()
  • 28902895111105 ()
11110

  • Manual scalpel blade, single-use
No Description
DEXIS LLC
10
In Commercial Distribution

  • EKAV100879340 ()
1.008.7934

  • Radiology information system application software
Humeral Spacer Connector 20 Connection D: 10 TiAl6V4 ELI sterile
Merete GmbH
10
In Commercial Distribution

  • 04048266179890 ()

  • Outer Diameter: 10 Millimeter
GB61001S

  • Diaphysis prosthesis
No Description
Merete GmbH
10
In Commercial Distribution

  • 04048266131812 ()

  • step: 10 mm
FH14010

  • Orthopaedic fixation plate, non-bioabsorbable
Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation
ProOcular Daily Disposable Contact Lens Power -10
CARLSBAD TECHNOLOGY INC.
-10
Not in Commercial Distribution

  • 40816816880655 ()
  • 30816816880658 ()
  • 10816816880654 ()
  • 00816816880657 ()


  • Soft corrective contact lens, daily-disposable
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal. The containers are designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture. In summary, all PureWay® Sharps Collector containers are blow molded using High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure. 2 gallon four pack sharps disposal ship back system (Includes four 2 gallon sharps container, box, bag, zip tie).
PUREWAY COMPLIANCE
10
In Commercial Distribution

  • 10853022008076 ()
  • 00853022008062 ()

  • Total Volume: 2.0 Gallon
40042

  • Sharps container
An electrically-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, a patient holding device (e.g., a sling, holder or a frame). It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.
Garaventa (Canada) Ltd.
10
In Commercial Distribution

  • B24010 ()


  • Stairlift, chair
SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
10
In Commercial Distribution

  • 07340024700023 ()


  • MRI system application software
TECHNO CUT CARBON STEEL STERILE SURGICAL BLADE #10 INDIVIDUALLY PACKED
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233118104 ()
  • 18904233118107 ()
  • 58904233118105 ()
  • 08904233118100 ()
01810

  • Manual scalpel blade, single-use
STAINLESS STEEL NON STERILE SURGICAL BLADE # 10 BULK PACKED
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 58904233117979 ()
  • 18904233117971 ()
  • 08904233117974 ()
01797

  • Manual scalpel blade, single-use
TECHNO CUT STAINLESS STEEL STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #10 INDIVIDUALLY PACKED MYCO REORDER # 6008T-10
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 58904233117665 ()
  • 18904233117667 ()
  • 08904233117660 ()
01766

  • Scalpel, single-use
The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Anovo Surgeon Console comprised of Arm Controllers (Joysticks and Thumbsticks), an Adjustable Controllers Stand, a PC with Touch Screen, Manual Release Tool and the Power Adapter, and allowing the operating surgeon to operate the Anovo Instrument Arms. There are two sets of Arm Controllers for the Anovo System: two Thumbsticks and two ARMS Controllers. The ARMS Controllers are enabled only when the system is at “resume” state and allow for the accurate control of the Anovo Instrument ARMS during the surgical procedure. Like the Anovo Instrument Arm, each ARMS Controllers has three joints: wrist, elbow and shoulder, so that each Anovo Instrument ARM moves accordingly to Controller's movement. The surgeon-held Controller handle is above the elbow joint and allows for multiple functionality transitions.
MOMENTIS SURGICAL LTD
10
In Commercial Distribution

  • 07290018151013 ()
  • 17290018151010 ()
FP-03-0003

  • Endoscopic electromechanical surgical system
TECHNO CUT PRO STAINLESS STEEL STERILE CARTRIDGE BLADE MANAGEMENT SYSTEM # 10 INDIVIDUALLY PACKED
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 58904233144715 ()
  • 18904233144717 ()
  • 08904233144710 ()
04471

  • Manual scalpel blade, single-use
TECHNO CUT HIGH CARBON STAINLESS STEEL STERILE SURGICAL BLADE # 10 WITH SILICON COATING INDIVIDUALLY PACKED
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233137402 ()
  • 18904233137405 ()
  • 58904233137403 ()
  • 08904233137408 ()
03740

  • Manual scalpel blade, single-use
STAINLESS STEEL NON STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #10 BULK PACKED MYCO REORDER # 6000CST-10
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233122965 ()
  • 18904233122968 ()
  • 58904233122966 ()
  • 08904233122961 ()
02296

  • Scalpel, single-use
GLASS VAN STAINLESS STEEL STERILE SURGICAL BLADE #10 INDIVIDUALLY PACKED MYCO REORDER # 3001T-10
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233118340 ()
  • 18904233118343 ()
  • 58904233118341 ()
  • 08904233118346 ()
01834

  • Manual scalpel blade, single-use
GLASS VAN CARBON STEEL STERILE SURGICAL BLADE #10 INDIVIDUALLY PACKED MYCO REORDER # 2001T-10
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233118319 ()
  • 18904233118312 ()
  • 58904233118310 ()
  • 08904233118315 ()
01831

  • Manual scalpel blade, single-use
No Description
Chemoment Materials Co., Ltd.
10
In Commercial Distribution

  • 06976009581106 ()


  • Silicone dental impression material
No Description
Sterilance Medical (Suzhou) Inc.
10#
In Commercial Distribution

  • 36945630112387 ()
  • 16945630112383 ()
  • 06945630112386 ()


  • Manual scalpel blade, single-use
Carbon Steel Surgical Blade,100pcs/box,10#
Sterilance Medical (Suzhou) Inc.
10#
In Commercial Distribution

  • 06945630101816 ()
  • 16945630101813 ()


  • Manual scalpel blade, single-use
No Description
Shandong Ruyue Medical Technology Co.,Ltd
10
In Commercial Distribution

  • 06973576425444 ()
  • 06973576425437 ()


  • Vinyl examination/treatment glove, non-powdered
No Description
Shandong Ruyue Medical Technology Co.,Ltd
10
In Commercial Distribution

  • 06973576425338 ()
  • 06973576425321 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Shandong Ruyue Medical Technology Co.,Ltd
10
In Commercial Distribution

  • 06973576425215 ()
  • 06973576425222 ()


  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
No Description
Directa AB
10
In Commercial Distribution

  • 17310236092107 ()
609210

  • Preformed dental crown, temporary
Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
10#
In Commercial Distribution

  • 26946430401278 ()
  • 16946430401271 ()
  • 06946430401274 ()


  • Oropharyngeal airway, single-use
Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
10#
In Commercial Distribution

  • 26946430401094 ()
  • 16946430401097 ()
  • 06946430401090 ()


  • Oropharyngeal airway, single-use
Emesis Basin, 26 Oz, Seamless Design, Dimensions 9-7/8" X 4-1/2" X 2-1/8"
Med Saver, Inc.
10
In Commercial Distribution

  • 00194613019600 ()


  • General-purpose bowl, reusable
AIR 10 TUBING ELBOW
RESMED PTY LTD
37394
In Commercial Distribution

  • 00619498373949 ()
37394

  • Ventilator breathing circuit, reusable
AIR 10 PSU 90W
RESMED PTY LTD
37344
In Commercial Distribution

  • 00619498373444 ()
37344

  • Home CPAP unit
AIR 10 SIDE COVER GRAY
RESMED PTY LTD
37335
In Commercial Distribution

  • 00619498373352 ()
37335

  • Home CPAP unit
AIR 10 AIR OUTLET
RESMED PTY LTD
37310
In Commercial Distribution

  • 00619498373109 ()
37310

  • Home CPAP unit
AIR 10 90W PSU
RESMED PTY LTD
37309
In Commercial Distribution

  • 00619498373093 ()
37309

  • Home CPAP unit
AIR 10 SIDE COVER CHARCOAL
RESMED PTY LTD
37303
In Commercial Distribution

  • 00619498373031 ()
37303

  • Home CPAP unit
AIR 10 OXIMETRY MODULE
RESMED PTY LTD
37302
In Commercial Distribution

  • 00619498373024 ()
37302

  • Home CPAP unit
AIR 10 USB MODULE
RESMED PTY LTD
37301
In Commercial Distribution

  • 00619498373017 ()
37301

  • Home CPAP unit
DC-DC CONVERTER
RESMED PTY LTD
37297
In Commercial Distribution

  • 00619498372973 ()
37297

  • Portable electric ventilator
No Description
EYEVAN INC.
NO.9 5(48) 48 15S-CL
In Commercial Distribution

  • 04582669019181 ()


  • Tinted non-prescription spectacles
No Description
EYEVAN INC.
NO.9 5(48) 48 13S-CL
In Commercial Distribution

  • 04582669019167 ()


  • Tinted non-prescription spectacles
No Description
EYEVAN INC.
NO.9 5(48) 48 12S-CL
In Commercial Distribution

  • 04582669019150 ()


  • Tinted non-prescription spectacles
No Description
EYEVAN INC.
NO.9 5(48) 48 11S-CL
In Commercial Distribution

  • 04582669019143 ()


  • Tinted non-prescription spectacles
No Description
EYEVAN INC.
NO.9 5(48) 48 4S-CL
In Commercial Distribution

  • 04582669019136 ()


  • Tinted non-prescription spectacles
No Description
Biomedica ADI Inc.
815L
In Commercial Distribution

  • 00850201006123 ()
  • 10850201006120 ()
815L

  • Lupus anticoagulant marker IVD, kit, clotting
No Description
Biomedica ADI Inc.
810
In Commercial Distribution

  • 00850201006017 ()
  • 10850201006014 ()
810

  • Lupus anticoagulant marker IVD, kit, clotting
No Description
ASAHI INTECC CO., LTD.
WAIN-CKI-10-300
In Commercial Distribution

  • 24547327085353 ()
  • 04547327085359 ()

  • Outer Diameter: 0.01 Inch
  • Length: 300 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
No Description
ASAHI INTECC CO., LTD.
WAIN-CKI-10-200
In Commercial Distribution

  • 24547327085346 ()
  • 04547327085342 ()

  • Outer Diameter: 0.01 Inch
  • Length: 200 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
2 Tip Straight Microcatheter
Stryker Corporation
M0031351090
In Commercial Distribution

  • 04546540688071 ()

  • Length: 150.0 Centimeter
  • Distal Length: 3.0 Centimeter
135109

  • Vascular microcatheter
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