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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ARMADA Nottingham One Step Dilator 6F/10F
ALLWIN MEDICAL DEVICES, INC.
ARMADA Nottingham One Step Dilator 6F/10F
In Commercial Distribution

  • 10812261012602 ()
  • 00812261012605 ()
NOT 6/10

  • Endoscopic-access dilator, single-use
NASAL, COTTLE, ANGLED, ONE BLADE SERRATED, TC
KLS-Martin L.P.
11-505-16-07
In Commercial Distribution

  • 00888118013354 ()

  • 16 CM


  • Nasal scissors
NASAL, FOMON, ANGLED, ONE BLADE SERRATED, TC
KLS-Martin L.P.
11-503-15-07
In Commercial Distribution

  • 00888118013347 ()

  • 15 CM


  • Nasal scissors
Robot Arm Interface instrument Rosa One 3.1
MEDTECH
174020-02
In Commercial Distribution

  • 00887868540028 ()
ROSAS00126

  • Multi-purpose stereotactic surgery system
Spetzler™ Lumbar Peritoneal Shunt, One Piece
Integra Lifesciences Corporation
NL8507210
In Commercial Distribution

  • 10381780024408 ()
  • M269NL85072101 ()
NL8507210

  • Cerebrospinal fluid shunt valve
IPS InLine One Dentcisal 20 g BL
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631850
In Commercial Distribution

631850

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 1
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631851
In Commercial Distribution

631851

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631852
In Commercial Distribution

631852

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 3
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631853
In Commercial Distribution

631853

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 4
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631854
In Commercial Distribution

631854

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 5
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631855
In Commercial Distribution

631855

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 6
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631856
In Commercial Distribution

631856

  • Dental appliance fabrication material, ceramic
One component bonding, self etch, light cure
Harvard Dental International GmbH
7083218
In Commercial Distribution

  • EHAR70832181 ()


  • Dentine bonding agent/set
Light cure total etch one component bonding
Harvard Dental International GmbH
7083607
In Commercial Distribution

  • EHAR70836071 ()


  • Dentine bonding agent/set
one side satin finished 9.5x7x0.5 - 0.6 cm
Spiggle & Theis Medizintechnik GmbH
10-733-09
In Commercial Distribution

  • 04250374712269 ()
10-733-09

  • Surgical cutting/shaping board, reusable
ACCLEAN ONE STEP FLUORIDE VARNISH MINT -200ct
HENRY SCHEIN, INC.
5700526
In Commercial Distribution

  • 10304040040529 ()
  • 00304040040522 ()
  • 20304040040526 ()

  • Total Volume: 0.4 Milliliter
5700526

  • Dental coating, tooth-desensitizing
ACCLEAN ONE STEP FLUORIDE VARNISH CHERRY -200ct
HENRY SCHEIN, INC.
5700525
In Commercial Distribution

  • 10304040040512 ()
  • 00304040040515 ()
  • 20304040040519 ()

  • Total Volume: 0.4 Milliliter
5700525

  • Dental coating, tooth-desensitizing
ACCLEAN ONE STEP FLUORIDE VARNISH CARAMEL -200ct
HENRY SCHEIN, INC.
5700524
In Commercial Distribution

  • 10304040040505 ()
  • 00304040040508 ()
  • 20304040040502 ()

  • Total Volume: 0.4 Milliliter
5700524

  • Dental coating, tooth-desensitizing
ACCLEAN ONE STEP FLUORIDE VARNISH RASPBERRY -50ct
HENRY SCHEIN, INC.
5700532
In Commercial Distribution

  • 10304040040482 ()
  • 00304040040485 ()
  • 20304040040489 ()

  • Total Volume: 0.4 Milliliter
5700532

  • Dental coating, tooth-desensitizing
ACCLEAN ONE STEP FLUORIDE VARNISH MINT -50ct
HENRY SCHEIN, INC.
5700531
In Commercial Distribution

  • 10304040040475 ()
  • 00304040040478 ()
  • 20304040040472 ()

  • Total Volume: 0.4 Milliliter
5700531

  • Dental coating, tooth-desensitizing
ACCLEAN ONE STEP FLUORIDE VARNISH CHERRY -50ct
HENRY SCHEIN, INC.
5700530
In Commercial Distribution

  • 10304040040468 ()
  • 00304040040461 ()
  • 20304040040465 ()

  • Total Volume: 0.4 Milliliter
5700530

  • Dental coating, tooth-desensitizing
ACCLEAN ONE STEP FLUORIDE VARNISH CARAMEL -50ct
HENRY SCHEIN, INC.
5700529
In Commercial Distribution

  • 10304040040451 ()
  • 00304040040454 ()
  • 20304040040458 ()

  • Total Volume: 0.4 Milliliter
5700529

  • Dental coating, tooth-desensitizing
ACCLEAN ONE STEP FLUORIDE VARNISH RASPBERRY -200ct
HENRY SCHEIN, INC.
5700527
In Commercial Distribution

  • 10304040040345 ()
  • 00304040040348 ()
  • 20304040040342 ()

  • Total Volume: 0.4 Milliliter
5700527

  • Dental coating, tooth-desensitizing
EXAFLEX® Catalyst (One pail 30 kg)
Gc America Inc.
138332
In Commercial Distribution

  • D6581383321 ()
138332

  • Silicone dental impression material
0.050'' Hex Screw Driver One Half Inch
TITAN IMPLANT INC
50 HEX DRIVER-1/2"
In Commercial Distribution

  • 00842448100047 ()


  • Surgical screwdriver, reusable
0.048'' Hex Screw Driver One Half Inch
TITAN IMPLANT INC
48 HEX DRIVER-1/2"
In Commercial Distribution

  • 00842448100023 ()


  • Surgical screwdriver, reusable
GC SPRAY-CIDE™ One Gallon Refill (3.8L)
Gc America Inc.
555128
Not in Commercial Distribution

  • D6585551282 ()
  • D6585551281 ()
555128

  • Medical device cleaning agent
Apyx One Console Helium Gas Regulator, Digital
APYX MEDICAL CORPORATION
APYX-HGSD
In Commercial Distribution

  • 00607151050276 ()
APYX-HGSD

  • Calibration gas cylinder regulator
A Series, Sys One, Heated Hum, CN
Respironics, Inc.
00
In Commercial Distribution

  • 00606959061668 ()
1147249

  • Heated respiratory humidifier
A40 ProEFL, System One HeatedTube Humidifier, Germany
Respironics, Inc.
DEX3T
In Commercial Distribution

  • 00606959058484 ()
DEX3T

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Humidifier, Italy
Respironics, Inc.
ITX3H
In Commercial Distribution

  • 00606959057951 ()
ITX3H

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Humidifier, Benelux
Respironics, Inc.
BLX3H
In Commercial Distribution

  • 00606959057944 ()
BLX3H

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Humidifier, Nordics
Respironics, Inc.
NDX3H
In Commercial Distribution

  • 00606959057937 ()
NDX3H

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Humidifier, France
Respironics, Inc.
FRX3H
In Commercial Distribution

  • 00606959057920 ()
FRX3H

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Humidifier, Iberia
Respironics, Inc.
ESX3H
In Commercial Distribution

  • 00606959057913 ()
ESX3H

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Humidifier, Germany
Respironics, Inc.
DEX3H
In Commercial Distribution

  • 00606959057890 ()
DEX3H

  • Heated respiratory humidifier
STOPCOCK LUER LOCK, ONE WAY MALE/FEMALE
HNM STAINLESS, LLC.
HNM-1-09-7955
In Commercial Distribution

  • 00842962109106 ()
HNM-1-09-7955

  • Suprapubic catheter introducer, reusable
Sizer with One Stop/0deg/9&10mm
Zavation LLC
ZAV-1333-11
In Commercial Distribution

  • 00197157006143 ()


  • Spinal fixation plate, non-bioabsorbable
Sizer with One Stop/0deg/5&6mm
Zavation LLC
ZAV-1333-09
In Commercial Distribution

  • 00197157006129 ()


  • Spinal fixation plate, non-bioabsorbable
Sizer with One Stop/10deg/9&10mm
Zavation LLC
ZAV-1333-07
In Commercial Distribution

  • 00197157006105 ()


  • Spinal fixation plate, non-bioabsorbable
10G, 15mm One Balloon Kit/Dual Access-AFX
Zavation LLC
VCF-1015-1ARX
In Commercial Distribution

  • 00197157005023 ()


  • Balloon kyphoplasty kit
10G, 20mm One Balloon Kit/Dual Access
Zavation LLC
VCF-1020-1RX
In Commercial Distribution

  • 00197157005009 ()


  • Balloon kyphoplasty kit
10G, 15mm One Balloon Kit/Dual Access
Zavation LLC
VCF-1015-1RX
In Commercial Distribution

  • 00197157004996 ()


  • Balloon kyphoplasty kit
Sizer with One Stop/0deg/11&12mm
Zavation LLC
ZAV-1333-12
In Commercial Distribution

  • 00197157006150 ()


  • Spinal fixation plate, non-bioabsorbable
Sizer with One Stop/0deg/7&8mm
Zavation LLC
ZAV-1333-10
In Commercial Distribution

  • 00197157006136 ()


  • Spinal fixation plate, non-bioabsorbable
Sizer with One Stop/10deg/11&12mm
Zavation LLC
ZAV-1333-08
In Commercial Distribution

  • 00197157006112 ()


  • Spinal fixation plate, non-bioabsorbable
Sizer with One Stop/10deg/7&8mm
Zavation LLC
ZAV-1333-06
In Commercial Distribution

  • 00197157006099 ()


  • Spinal fixation plate, non-bioabsorbable
Sizer with One Stop/10deg/5&6mm
Zavation LLC
ZAV-1333-05
In Commercial Distribution

  • 00197157006082 ()


  • Spinal fixation plate, non-bioabsorbable
Sizer with One Stop/6deg/11&12mm
Zavation LLC
ZAV-1333-04
In Commercial Distribution

  • 00197157006075 ()


  • Spinal fixation plate, non-bioabsorbable
Sizer with One Stop/6deg/9&10mm
Zavation LLC
ZAV-1333-03
In Commercial Distribution

  • 00197157006068 ()


  • Spinal fixation plate, non-bioabsorbable
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