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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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CENSITRAC READY IRIS SCISS CVD B/B 4 1/2"
SKLAR CORPORATION
47-1244C
In Commercial Distribution

  • 10649111390753 ()


  • Intraocular scissors, conventional-hinge, reusable
CENSITRAC READY IRIS SCISS STR B/B 4 1/2"
SKLAR CORPORATION
47-1144C
In Commercial Distribution

  • 10649111390715 ()


  • Intraocular scissors, conventional-hinge, reusable
CENSITRAC READY IRIS SCISS B/B STR 3 1/2"
SKLAR CORPORATION
47-1140C
In Commercial Distribution

  • 10649111390708 ()


  • Intraocular scissors, conventional-hinge, reusable
4 1/8 inch Stevens Tenotomy Scissor Curved, B/B
Surgical Direct, Inc.
SD90347710
In Commercial Distribution

  • B382SD903477100 ()
SD90347710

  • General-purpose surgical scissors, single-use
5 1/2 inch Stevens Tenotomy Scissors, Curved, B/B
Surgical Direct, Inc.
SD90321514
In Commercial Distribution

  • B382SD903215140 ()
SD90321514

  • General-purpose surgical scissors, single-use
5 1/2 inch Stevens Tenotomy Scissors, Straight, B/B
Surgical Direct, Inc.
SD90321414
In Commercial Distribution

  • B382SD903214140 ()
SD90321414

  • General-purpose surgical scissors, single-use
B&B MONO-POLAR ELECTROSURGICAL INSULATED FORCEP; 7"'(17.5CM), HAND SWITCHING
BLACK & BLACK SURGICAL, INC.
B65245
In Commercial Distribution

  • B089B652450 ()
B65245

  • Open-surgery electrosurgical electrode, monopolar, reusable
TransferCap (PC) Standard Abutment b/1.5/6.0 & b/3.0/6.0
Dentsply Implants Manufacturing GmbH
31045041
In Commercial Distribution

  • 07392532221057 ()
31045041

  • Dental implant suprastructure, temporary, preformed, single-use
TransferCap (PC) Standard Abutment b/1.5/4.0 & b/3.0/4.0
Dentsply Implants Manufacturing GmbH
31045031
In Commercial Distribution

  • 07392532221040 ()
31045031

  • Dental implant suprastructure, temporary, preformed, single-use
No Description
W.H. Holden, Inc.
11-0511
In Commercial Distribution

  • D9281105110 ()


  • Dental surgical scissors
No Description
W.H. Holden, Inc.
11-0512
In Commercial Distribution

  • D9281105120 ()


  • Dental surgical scissors
No Description
W.H. Holden, Inc.
11-0524
In Commercial Distribution

  • D9281105240 ()


  • Dental surgical scissors
No Description
W.H. Holden, Inc.
11-0523
In Commercial Distribution

  • D9281105230 ()


  • Dental surgical scissors
A hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.
N S SURGICAL COMPANY
02-006-16
In Commercial Distribution

  • G25002006160 ()

  • Length: 16 Centimeter
02-006-16

  • General-purpose surgical scissors, reusable
Tinted Liquid
JBC and Company
B
In Commercial Distribution

  • D851B0 ()
B

  • Dental appliance fabrication material, resin
No Description
CASCO BAY MOLDING LTD.
B
In Commercial Distribution

  • 00850036595243 ()


  • Teething device, non-fluid-filled
  • Mastication muscle exerciser
Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "B" is labeled for connections to electrodes 65-128.
NEURALYNX, INC.
-B
In Commercial Distribution

  • 00850011306383 ()
31-0602-0034

  • Electrical-only medical device connection cable, reusable
prolaio Convenience Kit - Model B
Prolaio, Inc.
B
In Commercial Distribution

  • 00850071330090 ()


  • Electrocardiography monitoring system receiver
To support drape over patient face
ADEPT MEDICAL LIMITED
B
In Commercial Distribution

  • 09421905187589 ()
AM1000B

  • Radiological arm/leg positioner
Support patient arm
ADEPT MEDICAL LIMITED
B
In Commercial Distribution

  • 09421905187572 ()
AM0180

  • Radiological arm/leg positioner
To support the sterile drape over the patient.
ADEPT MEDICAL LIMITED
B
In Commercial Distribution

  • 09421905187411 ()
AM1000B

  • Bedding support
The SuperBall Meniscal Repair System is a single patient, single use, an all-inside, all-suture meniscal repair device.
ARCURO MEDICAL LTD
B
In Commercial Distribution

  • 00850000630017 ()
SBD-SB-12-001

  • Polyester suture, non-bioabsorbable, multifilament
No Description
LUCERNO DYNAMICS, LLC
B
In Commercial Distribution

  • 00850014578169 ()
  • 00850014578008 ()
401874-230

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
B
In Commercial Distribution

  • 00850014578251 ()
  • 00850014578107 ()
401874-285

  • Scintillation-counter radiation survey meter
Convenience tray for the Macy Catheter. Contents include: Macy Catheter, 60ml Enteral/Oral Syringe, 10ml Enteral/Oral Syringe, 3ml Enteral/Oral Syringe, (2) 10ml Pre-filled Balloon Inflation Syringes, Macy Catheter Instructions for Use, 3-Ply Poly Towel, Nitrile Gloves, Lubricating Jelly, Catheter Securing Device.
HOSPI CORPORATION
B
In Commercial Distribution

  • 00861003000226 ()
  • 10861003000223 ()
MCT-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120 syringe infusion pump. Elite Biomedical Solutions does not manufacture the pump. The Dose Request Cord is an accessory for the pump and is available as a replacement part. The Dose Request Cord contains a handpiece with integral cable which plugs into the mating connector on the BD Alaris PCA Pump to allow the patient to request medication within the parameters entered into the syringe/infusion pump by the healthcare provider and the designed limits on the pumps. The Elite Biomedical Solutions Dose Request Cord has the same type of construction and technological characteristics as the predicate device, which is also a replacement bolus cable. Both the subject and predicate device are equivalent to the accessories supplied with the original pump. The Dose Request Cords are passive devices that contain no powered electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device.
Elite Biomedical Solutions LLC
B
In Commercial Distribution

  • 00860008635402 ()
10013795 EBS

  • Infusion pump remote control
4" Military Bandage - US (Rev B)
EINSTEIN WORKS, LLC
B
In Commercial Distribution

  • 00860017001281 ()
FCP-01

  • First aid absorbent pad/bandage
InnoVoyce Laser Fiber .600 1 Pack RFID
Innovoyce LLC
B
In Commercial Distribution

  • 00860011812173 ()
  • 00860011812142 ()
I0128-ASY-300063-600

  • General/multiple surgical laser system beam guide, single-use
InnoVoyce Laser Fiber .400 1 Pack RFID
Innovoyce LLC
B
In Commercial Distribution

  • 00860011812166 ()
  • 00860011812135 ()
I0128-ASY-300063-400

  • General/multiple surgical laser system beam guide, single-use
InnoVoyce Laser Fiber .300 1 Pack RFID
Innovoyce LLC
B
In Commercial Distribution

  • 00860011812159 ()
  • 00860011812128 ()
I0128-ASY-300063-300

  • General/multiple surgical laser system beam guide, single-use
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