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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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Surgical Direct - B382SD903215140

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

Surgical Direct - B382SD903214140

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

Sklar® - 10649111390715

CENSITRAC READY IRIS SCISS STR B/B 4 1/2"
SKLAR CORPORATION
47-1144C
In Commercial Distribution

  • 10649111390715 ()


  • Intraocular scissors, conventional-hinge, reusable

Sklar® - 10649111390753

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

  • 10649111390753 ()


  • Intraocular scissors, conventional-hinge, reusable

Sklar® - 10649111390746

CENSITRAC READY IRIS SCISS CVD B/B 3 1/2"
SKLAR CORPORATION
47-1240C
In Commercial Distribution

  • 10649111390746 ()


  • Intraocular scissors, conventional-hinge, reusable

Sklar® - 10649111390708

CENSITRAC READY IRIS SCISS B/B STR 3 1/2"
SKLAR CORPORATION
47-1140C
In Commercial Distribution

  • 10649111390708 ()


  • Intraocular scissors, conventional-hinge, reusable

Sklar Instruments - 10649111050121

ECONO STERILE OR SCIS STR B/B 5.5" STER CS50
SKLAR CORPORATION
96-2514
In Commercial Distribution

  • 50649111050129 ()
  • 10649111050121 ()


  • Dressing/utility forceps, scissors-like, single-use

ANKYLOS® - 07392532221057

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

ANKYLOS® - 07392532221040

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

SCISSORS OPER CRV B/B 6" - D9281105240

No Description
W.H. Holden, Inc.
11-0524
In Commercial Distribution

  • D9281105240 ()


  • Dental surgical scissors

SCISSORS OPER STR B/B 6" - D9281105230

No Description
W.H. Holden, Inc.
11-0523
In Commercial Distribution

  • D9281105230 ()


  • Dental surgical scissors

SCISSORS OPER CRV B/B 5" - D9281105120

No Description
W.H. Holden, Inc.
11-0512
In Commercial Distribution

  • D9281105120 ()


  • Dental surgical scissors

SCISSORS OPER STR B/B 5" - D9281105110

No Description
W.H. Holden, Inc.
11-0511
In Commercial Distribution

  • D9281105110 ()


  • Dental surgical scissors

Operating Scissor B/B 16cm straight - G25002006160

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

Cranberry Tinted Monomer - D851B0

Tinted Liquid
JBC and Company
B
In Commercial Distribution

  • D851B0 ()
B

  • Dental appliance fabrication material, resin

DiamondTOUCH™ - 00884450021262

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450021269 ()
  • 00884450021262 ()
  • 20884450021266 ()
IN9152

  • Catheter/overtube balloon inflator, single-use

DiamondTOUCH™ - 00884450021255

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450021252 ()
  • 00884450021255 ()
  • 20884450021259 ()
IN9135

  • Catheter/overtube balloon inflator, single-use

prolaio Convenience Kit - 00850071330090

prolaio Convenience Kit - Model B
Prolaio, Inc.
B
In Commercial Distribution

  • 00850071330090 ()


  • Electrocardiography monitoring system receiver

Macy Catheter Tray - 00861003000226

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

InnoVoyce Laser Fiber - 00860011812142

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 - 00860011812135

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 - 00860011812128

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

Elite Biomedical Solutions - 00860008635402

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

The Emergency Bandage - 00860017001281

4" Military Bandage - US (Rev B)
EINSTEIN WORKS, LLC
B
In Commercial Distribution

  • 00860017001281 ()
FCP-01

  • First aid absorbent pad/bandage

Performa® - 00884450770641

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450770648 ()
  • 00884450770641 ()

  • Label Long Description-MODIFIED HOOK
  • French Size (F)-4F
  • Length-65 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
7755-2M65

  • Angiographic catheter, single-use

Performa® - 00884450770634

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450770631 ()
  • 00884450770634 ()

  • Length-100 cm
  • French Size (F)-4F
  • Label Long Description-MODIFIED HOOK
  • Recommended Guide Wire-0.035" (0.89 mm)
7755-2M100

  • Angiographic catheter, single-use

Performa® - 00884450770566

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450770563 ()
  • 00884450770566 ()

  • French Size (F)-4F
  • Label Long Description-UHF PIGTAIL
  • Length-65 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
7742-2M65SH

  • Angiographic catheter, single-use

Performa® - 00884450770542

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450770542 ()

  • French Size (F)-4F
  • Recommended Guide Wire-0.035" (0.89 mm)
  • Label Long Description-UHF PIGTAIL
  • Length-100 cm
7742-20M65SH

  • Angiographic catheter, single-use

Performa® - 00884450769553

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450769550 ()
  • 00884450769553 ()

  • Length-100 cm
  • Label Long Description-UHF STRAIGHT FLUSH
  • Recommended Guide Wire-0.035" (0.89 mm)
  • French Size (F)-5F
7673-2M

  • Angiographic catheter, single-use

Performa® - 00884450769522

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450769522 ()

  • Label Long Description-UHF STRAIGHT FLUSH
  • Recommended Guide Wire-0.035" (0.89 mm)
  • Length-100 cm
  • French Size (F)-5F
7673-20M100SH

  • Angiographic catheter, single-use

Performa® - 00884450769508

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450769508 ()

  • Length-100 cm
  • Label Long Description-UHF STRAIGHT FLUSH
  • Recommended Guide Wire-0.035" (0.89 mm)
  • French Size (F)-5F
7673-11M100SH

  • Angiographic catheter, single-use

Performa® - 00884450769188

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450769185 ()
  • 00884450769188 ()

  • Recommended Guide Wire-0.035" (0.89 mm)
  • Label Long Description-MODIFIED HOOK
  • Length-65 cm
  • French Size (F)-5F
7603-2M65

  • Angiographic catheter, single-use

Performa® - 00884450769164

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450769164 ()

  • Length-65 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
  • French Size (F)-5F
  • Label Long Description-MODIFIED HOOK
7603-20M65SH

  • Angiographic catheter, single-use

Performa® - 00884450769157

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450769157 ()

  • Label Long Description-MODIFIED HOOK
  • Length-100 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
  • French Size (F)-5F
7603-20M100SH

  • Angiographic catheter, single-use

Performa® - 00884450769140

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450769140 ()

  • French Size (F)-5F
  • Recommended Guide Wire-0.035" (0.89 mm)
  • Label Long Description-MODIFIED HOOK
  • Length-65 cm
7603-11M65

  • Angiographic catheter, single-use

Performa® - 00884450769133

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450769133 ()

  • Label Long Description-MODIFIED HOOK
  • French Size (F)-5F
  • Length-100 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
7603-11M100

  • Angiographic catheter, single-use

Performa® - 00884450768938

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450768935 ()
  • 00884450768938 ()

  • Length-100 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
  • Label Long Description-UHF PIGTAIL
  • French Size (F)-5F
7602-2M

  • Angiographic catheter, single-use

Performa® - 00884450768907

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450768907 ()

  • Length-100 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
  • French Size (F)-5F
  • Label Long Description-UHF PIGTAIL
7602-20M100SH

  • Angiographic catheter, single-use

Performa® - 00884450767320

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450767320 ()

  • Recommended Guide Wire-0.035" (0.89 mm)
  • Label Long Description-UHF PIGTAIL
  • French Size (F)-5F
  • Length-100 cm
7602-20M

  • Angiographic catheter, single-use

Performa® - 00884450767306

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450767303 ()
  • 00884450767306 ()

  • Length-65 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
  • French Size (F)-5F
  • Label Long Description-UHF PIGTAIL
56535AVS2PIG

  • Angiographic catheter, single-use

Performa® - 00884450767153

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450767150 ()
  • 00884450767153 ()

  • Label Long Description-UHF PIGTAIL
  • Length-100 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
  • French Size (F)-5F
510035AVS2PIG

  • Angiographic catheter, single-use

Performa® - 00884450767115

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 00884450767115 ()

  • French Size (F)-4F
  • Recommended Guide Wire-0.035" (0.89 mm)
  • Length-65 cm
  • Label Long Description-MODIFIED HOOK
46535AVS20MHK

  • Angiographic catheter, single-use

Performa® - 00884450766705

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450766702 ()
  • 00884450766705 ()

  • Length-65 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
  • Internal Diameter-0.041" (1.04 mm)
  • French Size (F)-4F
1623-B62M

  • Angiographic catheter, single-use

Performa® - 00884450766545

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450766542 ()
  • 00884450766545 ()

  • French Size (F)-4F
  • Label Long Description-PEDIATRIC PIGTAIL
  • Length-65 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
7757-2MP65SHTCB

  • Angiographic catheter, single-use

Performa® - 00884450766514

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450766511 ()
  • 00884450766514 ()

  • Label Long Description-PEDIATRIC PIGTAIL
  • Recommended Guide Wire-0.035" (0.89 mm)
  • French Size (F)-4F
  • Length-65 cm
7757-2MP65SH

  • Angiographic catheter, single-use

Impress® - 00884450756706

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450756703 ()
  • 00884450756706 ()

  • Length-100 cm
  • Recommended Guide Wire-0.035" (0.89 mm)
  • Label Long Description-BENTSON 1
  • French Size (F)-4F
410035B1

  • Angiographic catheter, single-use

Impress® - 00884450755686

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450755683 ()
  • 00884450755686 ()

  • Recommended Guide Wire-0.038" (0.97 mm)
  • French Size (F)-4F
  • Label Long Description-MODIFIED HOOK 1
  • Length-80 cm
48038MHK1-H

  • Angiographic catheter, single-use

Impress® - 00884450755105

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450755102 ()
  • 00884450755105 ()

  • French Size (F)-5F
  • Label Long Description-PIGTAIL FLUSH
  • Recommended Guide Wire-0.038" (0.97 mm)
  • Length-110 cm
51103810PIG-NB

  • Angiographic catheter, single-use

PhD™ - 00884450746783

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450746780 ()
  • 00884450746783 ()
  • 20884450746787 ()
MAP804

  • Haemostasis valve
  • Angiography kit

Impress® - 00884450722343

No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450722340 ()
  • 00884450722343 ()

  • French Size (F)-5F
  • Length-80 cm
  • Label Long Description-MODIFIED HOOK 1
  • Recommended Guide Wire-0.038" (0.97 mm)
58038MHK1-H

  • Angiographic catheter, single-use
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