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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Brush Tips, 24 mm length, bag of 100
PULPDENT CORPORATION
BR
In Commercial Distribution

  • D701BR2 ()
  • D701BR1 ()


  • Dental material application tool, single-use
Package of 100
PULPDENT CORPORATION
APS100
In Commercial Distribution

  • D701APS1002 ()
  • D701APS1001 ()


  • Dental material application tool, single-use
RC-PREP 3CC SYRINGE TIP REFILL (50)
PREMIER DENTAL PRODUCTS COMPANY
9007139
In Commercial Distribution

  • D6919007139 ()


  • Dental material injection cannula, single-use
RC PREP PLASTIC 9G SYR TIP REFILL (50)
PREMIER DENTAL PRODUCTS COMPANY
9007127
In Commercial Distribution

  • D6919007127 ()


  • Dental material injection cannula, single-use
Inspiral Brush Tips 500pk
ULTRADENT PRODUCTS, INC.
1033-I
In Commercial Distribution

  • 00883205022998 ()
1033-I

  • Syringe tip cap
Black Mini Brush Tips 100pk
ULTRADENT PRODUCTS, INC.
1169
In Commercial Distribution

  • 00883205022035 ()
1169

  • Surgical/emergency suction cannula, non-illuminating, single-use
Inspiral Brush Tips 100pk
ULTRADENT PRODUCTS, INC.
123
In Commercial Distribution

  • 00883205021571 ()
123

  • Syringe tip cap
Opal Seal Tips 20 Pack
ULTRADENT PRODUCTS, INC.
500064-
In Commercial Distribution

  • 00883205015488 ()
500064-

  • Syringe tip cap
Opal Seal Tips 100 Pack
ULTRADENT PRODUCTS, INC.
500034-
In Commercial Distribution

  • 00883205015266 ()
500034-

  • Syringe tip cap
Opal Red Tips 20 Pack
ULTRADENT PRODUCTS, INC.
500018-
In Commercial Distribution

  • 00883205015235 ()
500018-

  • Syringe tip cap
COTTON APPLICATOR Ø 3.4MM WL 490MM TL 605mm
Richard Wolf GmbH
829651
In Commercial Distribution

  • 04055207009734 ()

  • Outer Diameter: 3.4 Millimeter
  • Length: 490 Millimeter
8296.51

  • Flexible endoscopic sponge/swab forceps
Integra® Jarit® Buck Applicator, Triangular End
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
380340
In Commercial Distribution

  • M2743803401 ()
  • 10381780198178 ()

  • 6-1/4"
  • Width: 1.1 Millimeter
380-340

  • General-purpose absorbent tip applicator/swab, reusable
Non Applicator multipack contains: - Organic Cotton Non Applicator Tampons Regular, 18 units - Organic Cotton Non Applicator Tampons Super, 12 units - Organic Cotton Non Applicator Tampons Super Plus, 10 units
Nutraceutical Corporation
Non Applicator Multipack
In Commercial Distribution

  • 00356163766407 ()
  • 00356163832119 ()
  • 00356163841760 ()


  • Menstrual tampon, unscented
No Description
Eye Ojo Corp.
HTS-601315A
In Commercial Distribution

  • 00666197825392 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HTS-EM-5002B
In Commercial Distribution

  • 00666197824975 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HT13-401-04-05
In Commercial Distribution

  • 00666197824968 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HT13-401-04-04
In Commercial Distribution

  • 00666197824944 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HT13-401-04-03
In Commercial Distribution

  • 00666197824937 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HT13-401-04-02
In Commercial Distribution

  • 00666197824920 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HT13-401-04-01
In Commercial Distribution

  • 00666197824913 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HT13-401-04-06
In Commercial Distribution

  • 00666197824890 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HTS-627435CL
In Commercial Distribution

  • 00666197824883 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HTSB2.0-622324
In Commercial Distribution

  • 00666197824685 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HTS-1133PK
In Commercial Distribution

  • 00666197824623 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HTS-621007
In Commercial Distribution

  • 00666197824319 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HTS-622357
In Commercial Distribution

  • 00666197824302 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HTS-617113SM
In Commercial Distribution

  • 00666197824272 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HTS-3PK
In Commercial Distribution

  • 00666197824227 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HTS-617113HG
In Commercial Distribution

  • 00666197824203 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HTS-690460
In Commercial Distribution

  • 00666197824197 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
HTS-625059
In Commercial Distribution

  • 00666197824180 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
OT-627032
In Commercial Distribution

  • 00666197777806 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
OT-627908
In Commercial Distribution

  • 00666197777790 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
OT-601061
In Commercial Distribution

  • 00666197777783 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
OT-601106
In Commercial Distribution

  • 00666197777776 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
OT-600983
In Commercial Distribution

  • 00666197777769 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
OT-627548
In Commercial Distribution

  • 00666197777752 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
OZFC-OPP
In Commercial Distribution

  • 00666197776618 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
OZFD-OPP16
In Commercial Distribution

  • 00666197775499 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
YUPL-16PK
In Commercial Distribution

  • 00666197775345 ()


  • Eye splash shield, reusable
No Description
Eye Ojo Corp.
OTPC-YUPL16
In Commercial Distribution

  • 00666197671197 ()


  • Eye splash shield, reusable
The AHI System is an adjunctive monitoring method to enable identification of patients who are showing signs of hemodynamic instability or are likely to experience a future episode of hemodynamic instability, and to allow clinicians an opportunity to increase vigilance.
Fifth Eye, Inc.
2
In Commercial Distribution

  • B823AHIV200 ()


  • Clinical management support software
Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making
Fifth Eye, Inc.
P1
In Commercial Distribution

  • B823AHIP100 ()


  • Clinical management support software
Canaloplasty Microcatheter Kit with Advanced Delivery System Kit Contents (1) Canaloplasty Microcatheter with Delivery System (2) Ophthalmic ViscoInjector
Nova Eye, Inc.
iTrack-ADS
In Commercial Distribution

  • 00893872001622 ()

  • Catheter Working Length: 45 Millimeter
  • Outer Diameter: 250 Micrometer
203000-0001

  • Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use
Optical Light Source: Fiberoptic Illuminator, Gen 2 iLumin series of revisions
Nova Eye, Inc.
FI-200
In Commercial Distribution

  • 00893872001608 ()
205000

  • Ophthalmic procedural light source unit
Opthalmic Viscoelastic Injector
Nova Eye, Inc.
ViscoInjector
In Commercial Distribution

  • 00893872001585 ()
202038

  • General-purpose syringe, single-use
Optical Light Source- Fiberoptic Illuminator
Nova Eye, Inc.
FI-100
In Commercial Distribution

  • 00893872001073 ()

  • Height: 8 Inch
  • Length: 14 Inch
  • Weight: 3.048 Pound
  • Height: 4 Inch
  • Width: 7 Inch
  • Depth: 4.5 Inch
200529

  • Ophthalmic procedural light source unit
Canaloplasty Microcatheter Kit Kit Contents: (1) Canaloplasty Microcatheter iTrack 250A (1) Opthalmic Viscoinjector
Nova Eye, Inc.
iTrack 250A
In Commercial Distribution

  • 00893872001059 ()

  • Outer Diameter: 250 Micrometer
  • Length: 12.5 Centimeter
  • Weight: 0.535 Pound
200478

  • Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use
Imaging Cap
Nova Eye, Inc.
IC-100
Not in Commercial Distribution

  • 893872001462 ()
  • 00893872001028 ()
200549

  • Cable/lead/sensor/probe cover, sterile
MC-V9462 CRYSTAL 55/17/145
New York Eye
MC9462-CRY-55
In Commercial Distribution

  • 00754317225334 ()


  • Tinted non-prescription spectacle lens
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