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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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Integra® Miltex® - 10381780462705

Integra® Miltex® Replacement Loupes Protective Caps, for Magnification 2.5X
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5028
In Commercial Distribution

  • H834150280 ()
  • 10381780462705 ()
1-5028

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462699

Integra® Miltex® Replacement Loupes Flip-up Paddle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5025
In Commercial Distribution

  • H834150250 ()
  • 10381780462699 ()
1-5025

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462682

Integra® Miltex® Replacement Loupes Frame, Black
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5024
In Commercial Distribution

  • H834150240 ()
  • 10381780462682 ()
1-5024

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462675

Integra® Miltex® Replacement Loupes Frame, Red
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5023
In Commercial Distribution

  • H834150230 ()
  • 10381780462675 ()
1-5023

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462668

Integra® Miltex® Loupes Prescription (Rx) Insert
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5022
In Commercial Distribution

  • H834150220 ()
  • 10381780462668 ()
1-5022

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462651

Integra® Miltex® Magnifying Loupe 3.5X, Black Frame, Extra Long, 18" to 22" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5021
In Commercial Distribution

  • H834150210 ()
  • 10381780462651 ()
1-5021

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462644

Integra® Miltex® Magnifying Loupe 3.5X, Black Frame, Long, 16" to 20" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5020
In Commercial Distribution

  • H834150200 ()
  • 10381780462644 ()
1-5020

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462637

Integra® Miltex® Magnifying Loupe 3.5X, Black Frame, Regular, 13" to 16" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5019
In Commercial Distribution

  • H834150190 ()
  • 10381780462637 ()
1-5019

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462620

Integra® Miltex® Magnifying Loupe 3.0X, Black Frame, Extra Long, 18" to 22" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5018
In Commercial Distribution

  • H834150180 ()
  • 10381780462620 ()
1-5018

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462613

Integra® Miltex® Magnifying Loupe 3.0X, Black Frame, Long, 16" to 21" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5017
In Commercial Distribution

  • H834150170 ()
  • 10381780462613 ()
1-5017

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462606

Integra® Miltex® Magnifying Loupe 3.0X, Black Frame, Regular, 13" to 16" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5016
In Commercial Distribution

  • H834150160 ()
  • 10381780462606 ()
1-5016

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462590

Integra® Miltex® Magnifying Loupe 3.0X, Black Frame, Short, 10" to 13" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5015
In Commercial Distribution

  • H834150150 ()
  • 10381780462590 ()
1-5015

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462583

Integra® Miltex® Magnifying Loupe 2.5X, Black Frame, Extra Long, 16" to 20" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5014
In Commercial Distribution

  • H834150140 ()
  • 10381780462583 ()
1-5014

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462576

Integra® Miltex® Magnifying Loupe 2.5X, Black Frame, Long, 14" to 18" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5013
In Commercial Distribution

  • H834150130 ()
  • 10381780462576 ()
1-5013

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462569

Integra® Miltex® Magnifying Loupe 2.5X, Black Frame, Regular, 12" to 16" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5012
In Commercial Distribution

  • H834150120 ()
  • 10381780462569 ()
1-5012

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462552

Integra® Miltex® Magnifying Loupe 2.5X, Black Frame, Short, 10" to 13" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5011
In Commercial Distribution

  • H834150110 ()
  • 10381780462552 ()
1-5011

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462545

Integra® Miltex® Magnifying Loupe 3.5X, Red Frame, Extra Long, 18" to 22" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5010
In Commercial Distribution

  • H834150100 ()
  • 10381780462545 ()
1-5010

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462538

Integra® Miltex® Magnifying Loupe 3.5X, Red Frame, Long, 16" to 20" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5009
In Commercial Distribution

  • H834150090 ()
  • 10381780462538 ()
1-5009

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462521

Integra® Miltex® Magnifying Loupe 3.5X, Red Frame, Regular, 13" to 16" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5008
In Commercial Distribution

  • H834150080 ()
  • 10381780462521 ()
1-5008

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462514

Integra® Miltex® Magnifying Loupe 3.0X, Red Frame, Extra Long, 18" to 22" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5007
In Commercial Distribution

  • H834150070 ()
  • 10381780462514 ()
1-5007

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462507

Integra® Miltex® Magnifying Loupe 3.0X, Red Frame, Long, 16" to 21" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5006
In Commercial Distribution

  • H834150060 ()
  • 10381780462507 ()
1-5006

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462491

Integra® Miltex® Magnifying Loupe 3.0X, Red Frame, Regular, 13" to 16" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5005
In Commercial Distribution

  • H834150050 ()
  • 10381780462491 ()
1-5005

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462484

Integra® Miltex® Magnifying Loupe 3.0X, Red Frame, Short, 10" to 13" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5004
In Commercial Distribution

  • H834150040 ()
  • 10381780462484 ()
1-5004

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462477

Integra® Miltex® Magnifying Loupe 2.5X, Red Frame, Extra Long, 16" to 20" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5003
In Commercial Distribution

  • H834150030 ()
  • 10381780462477 ()
1-5003

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462460

Integra® Miltex® Magnifying Loupe 2.5X, Red Frame, Long, 14" to 18" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5002
In Commercial Distribution

  • H834150020 ()
  • 10381780462460 ()
1-5002

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462453

Integra® Miltex® Magnifying Loupe 2.5X, Red Frame, Regular, 12" to 16" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5001
In Commercial Distribution

  • H834150010 ()
  • 10381780462453 ()
1-5001

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462446

Integra® Miltex® Magnifying Loupe 2.5X, Red Frame, Short, 10" to 13" Working Distance
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-5000
In Commercial Distribution

  • H834150000 ()
  • 10381780462446 ()
1-5000

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462293

Integra® Miltex® LED Loupes Light Filter, Flip-Up, For Use with Dental Composite
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
15061
In Commercial Distribution

  • H834150610 ()
  • 10381780462293 ()
15061

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462286

Integra® Miltex® Table Top Battery Charger for LED Loupes Light Unit
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
15059
In Commercial Distribution

  • H834150590 ()
  • 10381780462286 ()
15059

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462279

Integra® Miltex® AC Adapter for LED Loupes Light Unit
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
15058
In Commercial Distribution

  • H834150580 ()
  • 10381780462279 ()
15058

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462262

Integra® Miltex® Ion Battery for LED Loupes Light Unit
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
15057
In Commercial Distribution

  • H834150570 ()
  • 10381780462262 ()
15057

  • Surgical binoculars, reusable

Integra® Miltex® - 10381780462255

Integra® Miltex® LED Loupes Light Replacement Cable
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
15056
In Commercial Distribution

  • H834150560 ()
  • 10381780462255 ()
15056

  • Surgical binoculars, reusable

FILTER PI11 - 00814005024615

FILTER PI11
Quality Aspirators, Inc.
FILTER PI11
In Commercial Distribution

  • 00814005024615 ()
308-10089

  • Surgical binoculars, reusable

FILTER 5801 - 00814005024608

FILTER 5801
Quality Aspirators, Inc.
FILTER 5801
In Commercial Distribution

  • 00814005024608 ()
308-10088

  • Surgical binoculars, reusable

Eclipse-QDNP - 00814005024578

Eclipse-QDNP
Quality Aspirators, Inc.
Eclipse-QDNP
In Commercial Distribution

  • 00814005024578 ()
308-10087

  • Surgical binoculars, reusable

Eclipse Ti - 00814005024561

Eclipse Ti
Quality Aspirators, Inc.
Eclipse Ti
In Commercial Distribution

  • 00814005024561 ()
308-10086

  • Surgical binoculars, reusable

FILTER 5151 - 00814005024530

FILTER 5151
Quality Aspirators, Inc.
FILTER 5151
In Commercial Distribution

  • 00814005024530 ()
308-10084

  • Surgical binoculars, reusable

Q-Optics Loupe and Light Combo Case - 00814005024332

Q-Optics Loupe and Light Combo Case
Quality Aspirators, Inc.
Q-Optics Loupe and Light Combo Case
In Commercial Distribution

  • 00814005024332 ()
308-10028

  • Surgical binoculars, reusable

BRX - 00814005024325

BRX
Quality Aspirators, Inc.
BRX
In Commercial Distribution

  • 00814005024325 ()
308-10083

  • Surgical binoculars, reusable

SVRX - 00814005024318

SVRX
Quality Aspirators, Inc.
SVRX
In Commercial Distribution

  • 00814005024318 ()
308-10082

  • Surgical binoculars, reusable

Q-Optics Loupe Case - 00814005024240

Q-Optics Loupe Case
Quality Aspirators, Inc.
Q-Optics Loupe Case
In Commercial Distribution

  • 00814005024240 ()
308-10034

  • Surgical binoculars, reusable

EP-4.5 TTL - 00814005024233

EP-4.5 TTL
Quality Aspirators, Inc.
EP-4.5 TTL
In Commercial Distribution

  • 00814005024233 ()
308-10081

  • Surgical binoculars, reusable

EP-4.0 TTL - 00814005024226

EP-4.0 TTL
Quality Aspirators, Inc.
EP-4.0 TTL
In Commercial Distribution

  • 00814005024226 ()
308-10080

  • Surgical binoculars, reusable

EP-3.5 TTL - 00814005024219

EP-3.5 TTL
Quality Aspirators, Inc.
EP-3.5 TTL
In Commercial Distribution

  • 00814005024219 ()
308-10079

  • Surgical binoculars, reusable

F-3.0 TTL - 00814005024196

F-3.0 TTL
Quality Aspirators, Inc.
F-3.0 TTL
In Commercial Distribution

  • 00814005024196 ()
308-10077

  • Surgical binoculars, reusable

Q879 - 00814005023519

Q879
Quality Aspirators, Inc.
Q879
In Commercial Distribution

  • 00814005023519 ()
308-10037

  • Surgical binoculars, reusable

Q877 - 00814005023502

Q877
Quality Aspirators, Inc.
Q877
In Commercial Distribution

  • 00814005023502 ()
308-10036

  • Surgical binoculars, reusable

Prism Combo Case - 00814005023496

Prism Combo Case
Quality Aspirators, Inc.
Prism Combo Case
In Commercial Distribution

  • 00814005023496 ()
308-10042

  • Surgical binoculars, reusable

P-4.5 TTL - 00814005023472

P-4.5 TTL
Quality Aspirators, Inc.
P-4.5 TTL
In Commercial Distribution

  • 00814005023472 ()
308-10039

  • Surgical binoculars, reusable

P-4.0 TTL - 00814005023465

P-4.0 TTL
Quality Aspirators, Inc.
P-4.0 TTL
In Commercial Distribution

  • 00814005023465 ()
308-10038

  • Surgical binoculars, reusable
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