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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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Alteon - 10885862555465

ALT LNR TRL 10° FC G6 32
Exactech, Inc.
01-031-48-0632
In Commercial Distribution

  • 10885862555465 ()

  • Lumen/Inner Diameter: 32 Millimeter
  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
01-031-48-0632

  • Acetabulum prosthesis trial, prefabricated, reusable

Alteon - 10885862555427

ALT LNR TRL 10° FC G5 36
Exactech, Inc.
01-031-48-0536
In Commercial Distribution

  • 10885862555427 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
01-031-48-0536

  • Acetabulum prosthesis trial, prefabricated, reusable

Alteon - 10885862555410

ALT LNR TRL 10° FC G5 32
Exactech, Inc.
01-031-48-0532
In Commercial Distribution

  • 10885862555410 ()

  • Lateral angle of the face with respect to base plane
  • Lumen/Inner Diameter: 32 Millimeter
  • Angle: 10 degree
01-031-48-0532

  • Acetabulum prosthesis trial, prefabricated, reusable

Alteon - 10885862555380

ALT LNR TRL 10° FC G4 36
Exactech, Inc.
01-031-48-0436
In Commercial Distribution

  • 10885862555380 ()

  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
  • Lumen/Inner Diameter: 36 Millimeter
01-031-48-0436

  • Acetabulum prosthesis trial, prefabricated, reusable

Alteon - 10885862555373

ALT LNR TRL 10° FC G4 32
Exactech, Inc.
01-031-48-0432
In Commercial Distribution

  • 10885862555373 ()

  • Lumen/Inner Diameter: 32 Millimeter
  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
01-031-48-0432

  • Acetabulum prosthesis trial, prefabricated, reusable

Alteon - 10885862555335

ALT LNR TRL 10° FC G3 32
Exactech, Inc.
01-031-48-0332
In Commercial Distribution

  • 10885862555335 ()

  • Lateral angle of the face with respect to base plane
  • Lumen/Inner Diameter: 32 Millimeter
  • Angle: 10 degree
01-031-48-0332

  • Acetabulum prosthesis trial, prefabricated, reusable

Alteon - 10885862555328

ALT LNR TRL 10° FC G3 28
Exactech, Inc.
01-031-48-0328
In Commercial Distribution

  • 10885862555328 ()

  • Lateral angle of the face with respect to base plane
  • Lumen/Inner Diameter: 28 Millimeter
  • Angle: 10 degree
01-031-48-0328

  • Acetabulum prosthesis trial, prefabricated, reusable

Alteon - 10885862555304

ALT LNR TRL 10° FC G2 32
Exactech, Inc.
01-031-48-0232
In Commercial Distribution

  • 10885862555304 ()

  • Lateral angle of the face with respect to base plane
  • Angle: 10 degree
  • Lumen/Inner Diameter: 32 Millimeter
01-031-48-0232

  • Acetabulum prosthesis trial, prefabricated, reusable

Alteon - 10885862555274

ALT LNR TRL 10° FC G1 28
Exactech, Inc.
01-031-48-0128
In Commercial Distribution

  • 10885862555274 ()

  • Angle: 10 degree
  • Lateral angle of the face with respect to base plane
  • Lumen/Inner Diameter: 28 Millimeter
01-031-48-0128

  • Acetabulum prosthesis trial, prefabricated, reusable

Alteon - 10885862555588

ALT LNR TRL 10° FC G8 40
Exactech, Inc.
01-031-48-0840
In Commercial Distribution

  • 10885862555588 ()

  • Angle: 10 degree
  • Lumen/Inner Diameter: 40 Millimeter
  • Lateral angle of the face with respect to base plane
01-031-48-0840

  • Femoral head prosthesis trial

Wesper Lab - 00860007837029

Wesper Lab (“the device”) is a digital recording device designed to collect sleep data in adult patients as prescribed by a healthcare professional. Wesper Lab uses a set of multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a pulse oximeter to collect information about pulse rate and oxygen desaturations. The device employs a mobile application (“the app”), which resides on the patient’s personal mobile device, relaying sleep data wirelessly to a secure remote storage location (“the cloud”) for subsequent analysis by a healthcare professional. The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient. The device’s BLE ports connect to the following: 1. Abdominal patch 2. Thoracic patch 3. Pulse oximeter Data from the patches are transmitted via BLE throughout the night to the app, which uploads the data to the cloud. The third BLE port on the app connects to an authorized FDA-cleared pulse oximeter. This Device Identification is for a kit that is shipped without a charger.
Tatch Inc.
WSWW-RE-K-N-V02-BLO
In Commercial Distribution

  • 00860007837029 ()


  • Polysomnograph

Mr. Clear Purple - 00817984010136

Dry To The Touch
MECTRA LABS, INC.
0600-AF041-000
Not in Commercial Distribution

  • 10817984010133 ()
  • 00817984010136 ()
0600-AF041-000

  • Rigid optical laparoscope

PulStar - 00855341008006

The PulStar Spine Mobilization Device is intended for use by chiropractors, physical therapists and physicians for mobilization of the spine. The device consists of a hand-held impulse head attached to an electronic control module. The control module is connected to an Apple computer through a USB cable. Appropriate software is used to display the results of tissue compliance measurements. Intended Use and operation: Intended use of the PulStar is for the treatment of musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm and ligamentous strain. The clinician uses a hand held impulse head to test the stiffness of the patient’s spine at each vertebral level, the results of this procedure are recorded in the patient file in a computer database and displayed on the computer screen. The clinician then decides where therapy is needed and applies multiple impulses with the impulse head to those areas of the body of the patient with the intent of reducing spinal stiffness. After treatment, the clinician repeats the initial test of the patient’s spine to document changes in stiffness effected by the therapy.
Sense Technology, Inc.
G3
In Commercial Distribution

  • 10855341008003 ()
  • 00855341008006 ()


  • Joint/spinal manipulator, electronic

B-BOP® - 10381780051985

The plate bender is used to shape the plate according to the bone configuration.
NEWDEAL
189206ND
Not in Commercial Distribution

  • M248189206ND1 ()
  • 10381780051985 ()


  • Manual orthopaedic bender, reusable

CarboClear Cervical Plate System - 07290110207175

Used to direct the drill bit to prepare the screw pathway.
CARBOFIX ORTHOPEDICS LTD
Cervical Plate Drill Guide
In Commercial Distribution

  • 07290110207175 ()
PL940240

  • Surgical drill guide, reusable

Terumo® Advanced Perfusion System 1 - 00886799000847

Cable used to connect the data module to the intended device.
Terumo Cardiovascular Systems Corporation
804982
In Commercial Distribution

  • 00886799000847 ()
804982

  • Cardiopulmonary bypass system mounting unit

Roth Net - 00816765013656

The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711197
Not in Commercial Distribution

  • 10816765013653 ()
  • 00816765013656 ()

  • Outer Diameter: 2.5 Millimeter
  • Width: 3 Centimeter
  • Length: 230 Centimeter
00711197

  • Gastrointestinal/airway foreign body retrieval basket, single-use

Roth Net - 00816765012857

The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711159
Not in Commercial Distribution

  • 10816765012854 ()
  • 00816765012857 ()

  • Width: 3 Centimeter
  • Length: 230 Centimeter
  • Outer Diameter: 2.8 Millimeter
00711159

  • Gastrointestinal/airway foreign body retrieval basket, single-use

Roth Net - 00816765012710

The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711158
Not in Commercial Distribution

  • 10816765012717 ()
  • 00816765012710 ()

  • Width: 3 Centimeter
  • Outer Diameter: 2.8 Millimeter
  • Length: 230 Centimeter
00711158

  • Gastrointestinal/airway foreign body retrieval basket, single-use

Roth Net - 00724995220051

The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711200
In Commercial Distribution

  • 10724995220058 ()
  • 00724995220051 ()

  • Outer Diameter: 2.5 Millimeter
  • Width: 3 Centimeter
  • Length: 230 Centimeter
00711200

  • Gastrointestinal/airway foreign body retrieval basket, single-use

Roth Net - 00724995182854

The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711197
In Commercial Distribution

  • 10724995182851 ()
  • 00724995182854 ()
  • 00816765013656 ()

  • Width: 3 Centimeter
  • Outer Diameter: 2.5 Millimeter
  • Length: 230 Centimeter
00711197

  • Gastrointestinal/airway foreign body retrieval basket, single-use

Roth Net - 00724995182724

The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711159
In Commercial Distribution

  • 10724995182721 ()
  • 00724995182724 ()
  • 00816765012857 ()

  • Outer Diameter: 2.8 Millimeter
  • Length: 230 Centimeter
  • Width: 3 Centimeter
00711159

  • Gastrointestinal/airway foreign body retrieval basket, single-use

Roth Net - 00724995182717

The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711158
In Commercial Distribution

  • 10724995182714 ()
  • 00724995182717 ()
  • 00816765012710 ()

  • Outer Diameter: 2.8 Millimeter
  • Width: 3 Centimeter
  • Length: 230 Centimeter
00711158

  • Gastrointestinal/airway foreign body retrieval basket, single-use

Clarius Ultrasound Scanner - 07540205000403

No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software

Clarius Ultrasound Scanner - 07540205000397

No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software

3DIEMME RealGUIDE - 08050038830003

Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software

DryGuardians - 07350078445160

No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm

Roth Net - 00816765013519

The Roth Net retriever is used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711170
Not in Commercial Distribution

  • 10816765013516 ()
  • 00816765013519 ()

  • Length: 230 Centimeter
  • Width: 3 Centimeter
  • Outer Diameter: 2.5 Millimeter
00711170

  • Gastrointestinal/airway foreign body retrieval basket, single-use

Raptor - 00816765011317

The disposable Raptor grasping device is used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
US Endoscopy
00711177
Not in Commercial Distribution

  • 10816765011314 ()
  • 00816765011317 ()

  • Length: 230 Centimeter
  • Outer Diameter: 2.4 Millimeter
00711177

  • Flexible endoscopic tissue manipulation forceps, single-use

Raptor - 00724995183653

The disposable Raptor grasping device is used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
US Endoscopy
00711177
In Commercial Distribution

  • 10724995183650 ()
  • 00724995183653 ()
  • 00816765011317 ()

  • Length: 230 Centimeter
  • Outer Diameter: 2.4 Millimeter
00711177

  • Flexible endoscopic tissue manipulation forceps, single-use

Roth Net - 00724995182779

The Roth Net retriever is used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
US Endoscopy
00711170
In Commercial Distribution

  • 10724995182776 ()
  • 00724995182779 ()
  • 00816765013519 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 230 Centimeter
  • Width: 3 Centimeter
00711170

  • Gastrointestinal/airway foreign body retrieval basket, single-use

LungFit PH Verification Kit - B882900150

The LungFit PH Verification Kit (p/n 90015) is used during the Verification Check procedure to check the performance of the system before the system is attached to the patient circuit. The NDM is attached between the two open lengths of 22mm tubing and the gas sample line is attached to the sample T adaptor. A full description of how it is used is included in the LungFit PH Operators Manual section 9.3 (Beyond Air p/n 20038).
Beyond Air, Inc.
90015
In Commercial Distribution

  • B882900151 ()
  • B882900150 ()
  • B882900152 ()


  • Nitric oxide delivery unit, system-based

n.a. - 04048551107539

Socket, to clamp to the OR table
Karl Storz GmbH & Co. KG
28172HK
In Commercial Distribution

  • 04048551107539 ()
28172HK

  • Surgical instrument assist arm system, manually-adjusted

AUTO REFKERATOMETER - 04582273611788

No Description
TOMEY CORPORATION.
RC-800
In Commercial Distribution



  • Automated ophthalmic refractometer

AUTO REFKERATOMETER - 04582273600218

No Description
TOMEY CORPORATION.
RC-5000
In Commercial Distribution



  • Automated ophthalmic refractometer

AUTO REF-TOPOGRAPHER - 04582273612297

100V
TOMEY CORPORATION.
RT-7000
In Commercial Distribution

  • 04582273612297 ()


  • Automated ophthalmic refractometer

AUTO REFKERATOMETER - 04582273612273

100V
TOMEY CORPORATION.
RC-800
In Commercial Distribution

  • 04582273612273 ()


  • Automated ophthalmic refractometer

AUTO REFKERATOMETER - 04582273612242

100V
TOMEY CORPORATION.
RC-5000
In Commercial Distribution

  • 04582273612242 ()


  • Automated ophthalmic refractometer

AUTO REF-TOPOGRAPHER - 04582273600256

No Description
TOMEY CORPORATION.
RT-7000
In Commercial Distribution



  • Automated ophthalmic refractometer

ORA System® VerifEye™ - 00380659983283

ORA System with VerifEyeTM+, Aberometer 190.5
Alcon Laboratories, Inc.
8065998328
In Commercial Distribution

  • 00380659983283 ()


  • Automated ophthalmic refractometer

WaveLight - 00380659909634

WL ANALYZER II-USA
Alcon Laboratories, Inc.
8065990963
Not in Commercial Distribution

  • 00380659909634 ()


  • Automated ophthalmic refractometer

ORA System® VerifEye™ - 00380657530939

ORA System with VerifEyeTM+ 2.0, Cart
Alcon Laboratories, Inc.
8065753093
In Commercial Distribution

  • 00380657530939 ()


  • Automated ophthalmic refractometer

ORA System® VerifEye™ - 00380657529995

ORA System with VerifEyeTM Lynk, Aberrometer 184.5
Alcon Laboratories, Inc.
8065752999
In Commercial Distribution

  • 00380657529995 ()


  • Automated ophthalmic refractometer

ORA System® VerifEye™ - 00380657530038

ORA System with VerifEyeTM Lynk, Cart
Alcon Laboratories, Inc.
8065753003
In Commercial Distribution

  • 00380657530038 ()


  • Automated ophthalmic refractometer

ORA System® VerifEye™ - 00380657530014

ORA System with VerifEyeTM Lynk, Aberrometer 195.5
Alcon Laboratories, Inc.
8065753001
In Commercial Distribution

  • 00380657530014 ()


  • Automated ophthalmic refractometer

ORA System® VerifEye™ - 00380657530007

ORA System with VerifEyeTM Lynk, Aberrometer 190.5
Alcon Laboratories, Inc.
8065753000
In Commercial Distribution

  • 00380657530007 ()


  • Automated ophthalmic refractometer

Visionix - 04580606431942

Bear Chart SET
RIGHT MFG. CO., LTD.
Retinomax K+Screeen
In Commercial Distribution

  • 04580606431942 ()
VSN5400BB

  • Automated ophthalmic refractometer

Visionix - 04580606431935

Fireworks Chart SET
RIGHT MFG. CO., LTD.
Retinomax K+Screeen
In Commercial Distribution

  • 04580606431935 ()
VSN5400FB

  • Automated ophthalmic refractometer

Visionix - 04580606431928

Tulip Chart SET
RIGHT MFG. CO., LTD.
Retinomax K+Screeen
In Commercial Distribution

  • 04580606431928 ()
VSN5400TB

  • Automated ophthalmic refractometer

Visionix - 04580606431850

Bear Chart SET
RIGHT MFG. CO., LTD.
Retinomax Screeen
In Commercial Distribution

  • 04580606431850 ()
VSN5300BB

  • Automated ophthalmic refractometer
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