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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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Alcon - 00380650001504

GRAVITY FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° ABS* INTREPID* Hybrid Tip
Alcon Laboratories, Inc.
00380650001504
In Commercial Distribution

  • 10380650001501 ()
  • 00380650001504 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001498

GRAVITY FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip
Alcon Laboratories, Inc.
00380650001498
In Commercial Distribution

  • 10380650001495 ()
  • 00380650001498 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001481

GRAVITY FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 30° ABS* INTREPID* Balanced Tip
Alcon Laboratories, Inc.
00380650001481
In Commercial Distribution

  • 10380650001488 ()
  • 00380650001481 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001474

GRAVITY FMS, BASIC
Alcon Laboratories, Inc.
00380650001474
In Commercial Distribution

  • 10380650001471 ()
  • 00380650001474 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001467

ACTIVE FMS W/ 0.9MM INFUSION SLEEVES, 0.9MM 30° KELMAN* Mini-Flared ABS* Tip
Alcon Laboratories, Inc.
00380650001467
In Commercial Distribution

  • 10380650001464 ()
  • 00380650001467 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001450

ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 45° KELMAN* Mini-Flared ABS* Tip
Alcon Laboratories, Inc.
00380650001450
In Commercial Distribution

  • 10380650001457 ()
  • 00380650001450 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001443

ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 30° ABS* INTREPID* Hybrid Tip
Alcon Laboratories, Inc.
00380650001443
In Commercial Distribution

  • 10380650001440 ()
  • 00380650001443 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001436

ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 30° ABS* INTREPID* Hybrid Tip
Alcon Laboratories, Inc.
00380650001436
In Commercial Distribution

  • 10380650001433 ()
  • 00380650001436 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001429

ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 45° ABS* INTREPID* Hybrid Tip
Alcon Laboratories, Inc.
00380650001429
In Commercial Distribution

  • 10380650001426 ()
  • 00380650001429 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001412

ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 45° ABS* INTREPID* Hybrid Tip
Alcon Laboratories, Inc.
00380650001412
In Commercial Distribution

  • 10380650001419 ()
  • 00380650001412 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001405

ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° ABS* INTREPID* Hybrid Tip
Alcon Laboratories, Inc.
00380650001405
In Commercial Distribution

  • 10380650001402 ()
  • 00380650001405 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001399

ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip
Alcon Laboratories, Inc.
00380650001399
In Commercial Distribution

  • 10380650001396 ()
  • 00380650001399 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001382

ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9MM 30° ABS* INTREPID* Balanced Tip
Alcon Laboratories, Inc.
00380650001382
In Commercial Distribution

  • 10380650001389 ()
  • 00380650001382 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001375

ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° KELMAN* ABS* Mini Tip
Alcon Laboratories, Inc.
00380650001375
In Commercial Distribution

  • 10380650001372 ()
  • 00380650001375 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001368

ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip
Alcon Laboratories, Inc.
00380650001368
In Commercial Distribution

  • 10380650001365 ()
  • 00380650001368 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001351

ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9MM 30° ABS* INTREPID* Balanced Tip
Alcon Laboratories, Inc.
00380650001351
In Commercial Distribution

  • 10380650001358 ()
  • 00380650001351 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001344

ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip
Alcon Laboratories, Inc.
00380650001344
In Commercial Distribution

  • 10380650001341 ()
  • 00380650001344 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001337

ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 30° ABS* INTREPID* Balanced Tip
Alcon Laboratories, Inc.
00380650001337
In Commercial Distribution

  • 10380650001334 ()
  • 00380650001337 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001320

ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° KELMAN* Mini-Flared ABS* Tip
Alcon Laboratories, Inc.
00380650001320
In Commercial Distribution

  • 10380650001327 ()
  • 00380650001320 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001313

ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 30° KELMAN* Mini-Flared ABS* Tip
Alcon Laboratories, Inc.
00380650001313
In Commercial Distribution

  • 10380650001310 ()
  • 00380650001313 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001306

ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9 MM Tipless
Alcon Laboratories, Inc.
00380650001306
In Commercial Distribution

  • 10380650001303 ()
  • 00380650001306 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001290

ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9 MM Tipless
Alcon Laboratories, Inc.
00380650001290
In Commercial Distribution

  • 10380650001297 ()
  • 00380650001290 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001283

ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9 MM Tipless
Alcon Laboratories, Inc.
00380650001283
In Commercial Distribution

  • 10380650001280 ()
  • 00380650001283 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380650001276

ACTIVE FMS, BASIC
Alcon Laboratories, Inc.
00380650001276
In Commercial Distribution

  • 10380650001273 ()
  • 00380650001276 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

UNITY - 00380650001252

22GA Fragmentation Pack
Alcon Laboratories, Inc.
00380650001252
In Commercial Distribution

  • 10380650001259 ()
  • 00380650001252 ()

  • 22 Gauge
8065000125

  • Ophthalmic surgical procedure kit, non-medicated, single-use

CONSTELLATION® HYPERVIT® TOTAL PLUS® - 00380650000965

27+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Combined Procedure Pak
Alcon Laboratories, Inc.
8065000096
In Commercial Distribution

  • 10380650000962 ()
  • 00380650000965 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

CONSTELLATION® HYPERVIT® TOTAL PLUS® - 00380650000958

25+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Combined Procedure Pak
Alcon Laboratories, Inc.
8065000095
In Commercial Distribution

  • 10380650000955 ()
  • 00380650000958 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

27+ - 00380657516971

27+ Valved Entry System (3-CT)
Alcon Laboratories, Inc.
8065751697
In Commercial Distribution

  • 10380657516978 ()
  • 00380657516971 ()

  • 27 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380657516582

25 GA Valved Entry System, 3-CT
Alcon Laboratories, Inc.
8065751658
In Commercial Distribution

  • 10380657516589 ()
  • 00380657516582 ()

  • 25 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380657516575

23 Ga Valved Trocar Cannula Entry System, 3 ct
Alcon Laboratories, Inc.
8065751657
In Commercial Distribution

  • 10380657516572 ()
  • 00380657516575 ()

  • 23 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Constellation, Ultravit, 25+, TotalPlus, EdgePlus - 00380657516186

Constellation Vision System 7500 CPM UltraVit Probe Wide Angle Endoilluminator 25+ TotalPlus Vitrectomy Pak EdgePlus Blade Valved Entry System
Alcon Laboratories, Inc.
8065751618
In Commercial Distribution

  • 10380657516183 ()
  • 00380657516186 ()

  • 25 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Constellation, Ultravit, 25+, TotalPlus, EdgePlus - 00380657516179

Constellation Vision System 7500 CPM UltraVit Probe Straight Endoilluminator 25+ TotalPlus Vitrectomy Pak EdgePlus Blade Valved Entry System
Alcon Laboratories, Inc.
8065751617
In Commercial Distribution

  • 10380657516176 ()
  • 00380657516179 ()

  • 25 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Constellation, Ultravit, TotalPlus, EdgePlus - 00380657516148

Constellation Vision System 7500 CPM UltraVit Probe Wide Angle Endoilluminator 23GA TotalPlus Vitrectomy Pak EdgePlus Blade Valved Entry System
Alcon Laboratories, Inc.
8065751614
In Commercial Distribution

  • 10380657516145 ()
  • 00380657516148 ()

  • 23 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Constellation, Ultravit, TotalPlus, EdgePlus - 00380657516131

Constellation Vision System 7500 CPM UltraVit Probe Straight Endoilluminator 23GA TotalPlus Vitrectomy Pak EdgePlus Blade Valved Entry System
Alcon Laboratories, Inc.
8065751613
In Commercial Distribution

  • 10380657516138 ()
  • 00380657516131 ()

  • 23 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380657515783

23 GA Pik Endoilluminator
Alcon Laboratories, Inc.
8065751578
Not in Commercial Distribution

  • 10380657515780 ()
  • 00380657515783 ()

  • 23 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Engauge - 00380657515776

25 GA Chandelier
Alcon Laboratories, Inc.
8065751577
In Commercial Distribution

  • 10380657515773 ()
  • 00380657515776 ()

  • 25 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Accurus, 25+, Alcon - 00380657514939

Total Plus 25+ Vitrectomy Pak for use with: Accurus Vitrectomy System
Alcon Laboratories, Inc.
8065751493
Not in Commercial Distribution

  • 10380657514936 ()
  • 00380657514939 ()

  • 25+ Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Accurus, 25+, Alcon - 00380657514915

Combined Procedure Pak with Accurus 25+ Vitrectomy Probe (0.9 mm Tipless)
Alcon Laboratories, Inc.
8065751491
Not in Commercial Distribution

  • 10380657514912 ()
  • 00380657514915 ()

  • 25+ Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Engauge - 00380657514861

25+® Wide Angle Endoilluminator
Alcon Laboratories, Inc.
8065751486
In Commercial Distribution

  • 10380657514868 ()
  • 00380657514861 ()

  • 25 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

25+ - 00380657514854

25+™ Wide Angle Endoilluminator
Alcon Laboratories, Inc.
8065751485
Not in Commercial Distribution

  • 10380657514851 ()
  • 00380657514854 ()

  • 25 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Constellation, Ultravit, 25+, TotalPlus, Engauge - 00380657514687

Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 25+ TotalPlus Combined Procedure Pak Engauge RFID 0.9mm Tipless Anterior Kit
Alcon Laboratories, Inc.
8065751468
In Commercial Distribution

  • 10380657514684 ()
  • 00380657514687 ()

  • 25 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Constellation, Ultravit, 25+, TotalPlus, Engauge - 00380657514663

Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 25+ TotalPlus Combined Procedure Pak Engauge RFID 1.1mm Tipless Anterior Kit
Alcon Laboratories, Inc.
8065751466
Not in Commercial Distribution

  • 10380657514660 ()
  • 00380657514663 ()

  • 25 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Constellation, Ultravit, 25+, TotalPlus, Engauge - 00380657514625

Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 25+ TotalPlus Vitrectomy Pak Engauge RFID
Alcon Laboratories, Inc.
8065751462
In Commercial Distribution

  • 10380657514622 ()
  • 00380657514625 ()

  • 25 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380657514595

25 Ga Infusion Cannula
Alcon Laboratories, Inc.
8065751459
Not in Commercial Distribution

  • 10380657514592 ()
  • 00380657514595 ()

  • 25 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380657514472

23 GA Entry System, Enhanced, 3-CT
Alcon Laboratories, Inc.
8065751447
In Commercial Distribution

  • 10380657514479 ()
  • 00380657514472 ()

  • 23 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380657514465

23 Gauge Entry System, Enhanced, 1 ea
Alcon Laboratories, Inc.
8065751446
In Commercial Distribution

  • 10380657514462 ()
  • 00380657514465 ()

  • 23 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Alcon - 00380657514434

25 GA Trocar Plugs
Alcon Laboratories, Inc.
8065751443
In Commercial Distribution

  • 10380657514431 ()
  • 00380657514434 ()

  • 25 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Constellation - 00380657509584

20 GA Fragmentation Pak
Alcon Laboratories, Inc.
8065750958
In Commercial Distribution

  • 10380657509581 ()
  • 00380657509584 ()

  • 20 Gauge


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Constellation - 00380657509577

Viscous Fluid Control Pak
Alcon Laboratories, Inc.
8065750957
In Commercial Distribution

  • 10380657509574 ()
  • 00380657509577 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

Constellation - 00380657509201

Constellation Vision System GFI Admin Tubing Set
Alcon Laboratories, Inc.
8065750920
In Commercial Distribution

  • 10380657509208 ()
  • 00380657509201 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
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