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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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No Description
MANI, INC.
10
In Commercial Distribution

  • 04546951500016 ()
  • 14546951500013 ()
10

  • Nylon suture, non-bioabsorbable, monofilament
Kids Size Silicone Earplugs - 6 pair box - Orange
McKeon Products, Inc.
Kids Size Soft Moldable Silicone Putty Earplugs
In Commercial Distribution

  • 10033732000106 ()
  • 00033732000109 ()
10

  • Earplugs, reusable
NRHZ: A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial's sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial's contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device.
DRAGON HEART MEDICAL, INC.
R001
Not in Commercial Distribution

  • B346R0011 ()
  • B346R00129 ()
10

  • Medical air terminal unit
No Description
DOLABANY EYEWEAR
AT8399 C2
In Commercial Distribution

  • 00818399254184 ()
10

  • Tinted non-prescription spectacles
Tinted Glow Powder
JBC and Company
10
In Commercial Distribution

  • D85110 ()
10

  • Dental appliance fabrication material, resin
3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Upper Right Centrals, Size 10, 10
3M COMPANY
10
In Commercial Distribution

  • 50605861025312 ()
  • 30605861025318 ()
  • 00605861022392 ()
10

  • Preformed dental crown, temporary
Open width8±1mm the max OD of insertion part 2.6mm working length 2350mm coated
Micro-Tech (Nanjing) Co., Ltd.
ROCC-C-26-235-C
Not in Commercial Distribution

  • 26932503530228 ()
  • 16932503530221 ()
  • 06932503530224 ()
ROCC-C-26-235-C

  • Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Convenience kit containing Zinc PVA, Formalin and C&S Vials.
MEDICAL CHEMICAL CORPORATION
891-03
In Commercial Distribution

  • M445891030 ()
  • M445891031 ()
891-03

  • Fixative, metallic
  • 10% Neutral buffered formalin IVD
  • Carey-Blair transport medium IVD
The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Ovesco Endoscopy AG
10
Not in Commercial Distribution

  • 04260206310839 ()
  • 04260206310846 ()

  • mounting depht of the cap: 5 mm
  • for endoscopes with diameter 5.5 - 6 mm
  • Length: 20.6 Millimeter
  • Outer Diameter: 10.1 Millimeter
400.31.03

  • Endoscopic gastrointestinal stenosis dilator
The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician.
Noras MRI products GmbH
10
In Commercial Distribution

  • 04251269207389 ()
118890

  • MRI system coil, radio-frequency
TIDI Positioning Aid Kits Kit, Various Sizes 6 per Set
TIDI PRODUCTS, LLC
10
Not in Commercial Distribution

  • 00618125168248 ()


  • Multifunction body cushion
Grid Pad Go 10, speech generating device
Talk To ME Technologies, LLC
10
In Commercial Distribution

  • 00850041729190 ()


  • Voice synthesizer/digitizer
Talk Pad 10: Wego Edition Speech Generating Device
Talk To ME Technologies, LLC
10
In Commercial Distribution

  • 00850041729138 ()


  • Voice synthesizer/digitizer
zuvo 10 speech generating device
Talk To ME Technologies, LLC
10
In Commercial Distribution

  • 00850041729046 ()


  • Voice synthesizer/digitizer
KIATO PLUS Sterile Carbon Steel Rib Back Surgical Blade Box of 100 size 10. Sterilized by Gamma irradiation
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895182105 ()
  • 08902895182101 ()
18210

  • Manual scalpel blade, single-use
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 PLUS Sterile Carbon steel Surgical Blade box of 100 size 10. Sterilized by Gamma irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895180101 ()
  • 08902895180107 ()
18010

  • 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
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
10
In Commercial Distribution

  • 00860461001776 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
NEOCOIL, LLC
10
In Commercial Distribution

  • 00856181003107 ()


  • MRI system coil, radio-frequency
Picis Weight Based Dose Converter: The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient’s dose for a given agent based on a weight based determination by the clinician.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007085 ()


  • Patient health record information system application software
Picis Perioperative and Critical Care: An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007078 ()


  • Patient health record information system application software
The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution

  • 00860010575307 ()


  • Ultrasound imaging system application software
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
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
Sample collection kit
Biodesix, Inc.
10
In Commercial Distribution

  • G292510 ()
51

  • Blood collection set, invasive
CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external
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