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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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UNITY - 00380650004185

UNITY™ Tray Support Cover (Small)
Alcon Laboratories, Inc.
00380650004185
In Commercial Distribution

  • 10380650004182 ()
  • 00380650004185 ()
8065000418

  • Medical equipment/instrument drape, single-use

NGENUITY - 00380650003997

Microsurgical Camera
Alcon Laboratories, Inc.
00380650003997
In Commercial Distribution

  • 00380650003997 ()
8065000399

  • Microscope video camera

UNITY - 00380650003966

27GA Short Unity Infusion Cannula with Tubing Management Device
Alcon Laboratories, Inc.
00380650003966
In Commercial Distribution

  • 10380650003963 ()
  • 00380650003966 ()
8065000396

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

UNITY - 00380650003959

25GA Short Unity Infusion Cannula with Tubing Management Device
Alcon Laboratories, Inc.
00380650003959
In Commercial Distribution

  • 10380650003956 ()
  • 00380650003959 ()
8065000395

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

UNITY - 00380650003911

UNITY™ Tray Support Cover (Large)
Alcon Laboratories, Inc.
00380650003911
In Commercial Distribution

  • 10380650003918 ()
  • 00380650003911 ()
8065000391

  • Medical equipment/instrument drape, single-use

UNITY - 00380650003904

UNITY™ Monitor Cover
Alcon Laboratories, Inc.
00380650003904
In Commercial Distribution

  • 10380650003901 ()
  • 00380650003904 ()
8065000390

  • Medical equipment/instrument drape, single-use

UNITY - 00380650003850

27+ UNITY TOTALPLUS™ Combined Procedure Pack, UES HyperVit™ 30K DS, Wide Angle DS, Ultra, 45° Hybrid Tip
Alcon Laboratories, Inc.
00380650003850
In Commercial Distribution

  • 10380650003857 ()
  • 00380650003850 ()
8065000385

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

UNITY - 00380650003843

27+ UNITY TOTALPLUS™ Combined Procedure Pack, UES HyperVit™ 30K DS, Wide Angle DS, Ultra, 30° Hybrid Tip
Alcon Laboratories, Inc.
00380650003843
In Commercial Distribution

  • 10380650003840 ()
  • 00380650003843 ()
8065000384

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

UNITY - 00380650003836

27+ UNITY TOTALPLUS Combined Procedure Pack, UES HyperVit 30K DS, Wide Angle DS, Ultra, 45° Balanced Tip
Alcon Laboratories, Inc.
00380650003836
In Commercial Distribution

  • 10380650003833 ()
  • 00380650003836 ()
8065000383

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

UNITY - 00380650003829

27+ UNITY TOTALPLUS Combined Procedure Pack, UES HyperVit 30K DS, Wide Angle DS, Ultra, 30° Balanced Tip
Alcon Laboratories, Inc.
00380650003829
In Commercial Distribution

  • 10380650003826 ()
  • 00380650003829 ()
8065000382

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

UNITY - 00380650003805

25+ UNITY TOTALPLUS™ Combined Procedure Pack, UES HyperVit™ 30K, Straight, Ultra, 45° Hybrid Tip
Alcon Laboratories, Inc.
00380650003805
In Commercial Distribution

  • 10380650003802 ()
  • 00380650003805 ()
8065000380

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

UNITY - 00380650003799

25+ UNITY TOTALPLUS™ Combined Procedure Pack, UES HyperVit™ 30K, Straight, Ultra, 30° Hybrid Tip
Alcon Laboratories, Inc.
00380650003799
In Commercial Distribution

  • 10380650003796 ()
  • 00380650003799 ()
8065000379

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

UNITY - 00380650003782

25+ UNITY TOTALPLUS™ Combined Procedure Pack, UES HyperVit™ 30K, Straight, Ultra, 45° Balanced Tip
Alcon Laboratories, Inc.
00380650003782
In Commercial Distribution

  • 10380650003789 ()
  • 00380650003782 ()
8065000378

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

UNITY - 00380650003775

25+ UNITY TOTALPLUS™ Combined Procedure Pack, UES HyperVit™ 30K, Straight, Ultra, 30° Balanced Tip
Alcon Laboratories, Inc.
00380650003775
In Commercial Distribution

  • 10380650003772 ()
  • 00380650003775 ()
8065000377

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

UNITY - 00380650003683

25+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES UltraVit™ 10K, Straight, Ultra, 45° Balanced Tip
Alcon Laboratories, Inc.
00380650003683
In Commercial Distribution

  • 10380650003680 ()
  • 00380650003683 ()
8065000368

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

UNITY - 00380650003676

25+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES UltraVit™ 10K, Straight, Ultra, 30° Balanced Tip
Alcon Laboratories, Inc.
00380650003676
In Commercial Distribution

  • 10380650003673 ()
  • 00380650003676 ()
8065000367

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

UNITY - 00380650003669

25+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES UltraVit™ 10K, Straight, Ultra, Tipless
Alcon Laboratories, Inc.
00380650003669
In Commercial Distribution

  • 10380650003666 ()
  • 00380650003669 ()
8065000366

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

UNITY - 00380650003638

23Ga UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES UltraVit™ 10K, Straight, Ultra, 45° Balanced Tip
Alcon Laboratories, Inc.
00380650003638
In Commercial Distribution

  • 10380650003635 ()
  • 00380650003638 ()
8065000363

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

UNITY - 00380650003621

23Ga UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES UltraVit™ 10K, Straight, Ultra, 30° Balanced Tip
Alcon Laboratories, Inc.
00380650003621
In Commercial Distribution

  • 10380650003628 ()
  • 00380650003621 ()
8065000362

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

UNITY - 00380650003614

23Ga UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES UltraVit™ 10K, Straight, Ultra, Tipless
Alcon Laboratories, Inc.
00380650003614
In Commercial Distribution

  • 10380650003611 ()
  • 00380650003614 ()
8065000361

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

UNITY - 00380650003461

UNITY Cataract FMS Pack, 45° Hybrid Tip with Nano Infusion Sleeves
Alcon Laboratories, Inc.
00380650003461
In Commercial Distribution

  • 10380650003468 ()
  • 00380650003461 ()
8065000346

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

UNITY - 00380650003454

UNITY Cataract FMS Pack, 30° Hybrid Tip with Nano Infusion Sleeves
Alcon Laboratories, Inc.
00380650003454
In Commercial Distribution

  • 10380650003451 ()
  • 00380650003454 ()
8065000345

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

UNITY - 00380650003447

UNITY Cataract FMS Pack, 45° Balanced Tip with Nano Infusion Sleeves
Alcon Laboratories, Inc.
00380650003447
In Commercial Distribution

  • 00380650003447 ()
  • 10380650003444 ()
8065000344

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

UNITY - 00380650003430

UNITY Cataract FMS Pack, 30° Balanced Tip with Nano Infusion Sleeves
Alcon Laboratories, Inc.
00380650003430
In Commercial Distribution

  • 10380650003437 ()
  • 00380650003430 ()
8065000343

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

UNITY - 00380650003423

UNITY Cataract FMS Pack, 45° Hybrid Tip with Ultra Infusion Sleeves
Alcon Laboratories, Inc.
00380650003423
In Commercial Distribution

  • 10380650003420 ()
  • 00380650003423 ()
8065000342

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

UNITY - 00380650003416

UNITY Cataract FMS Pack, 30° Hybrid Tip with Ultra Infusion Sleeves
Alcon Laboratories, Inc.
00380650003416
In Commercial Distribution

  • 10380650003413 ()
  • 00380650003416 ()
8065000341

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

UNITY - 00380650003409

UNITY Cataract FMS Pack, 45° Balanced Tip with Ultra Infusion Sleeves
Alcon Laboratories, Inc.
00380650003409
In Commercial Distribution

  • 10380650003406 ()
  • 00380650003409 ()
8065000340

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

UNITY - 00380650003393

UNITY Cataract FMS Pack, 30° Balanced Tip with Ultra Infusion Sleeves
Alcon Laboratories, Inc.
00380650003393
In Commercial Distribution

  • 10380650003390 ()
  • 00380650003393 ()
8065000339

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

UNITY - 00380650003386

UNITY Cataract FMS Pack, 45° Hybrid Tip with Micro Infusion Sleeves
Alcon Laboratories, Inc.
00380650003386
In Commercial Distribution

  • 10380650003383 ()
  • 00380650003386 ()
8065000338

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

UNITY - 00380650003379

UNITY Cataract FMS Pack, 30° Hybrid Tip with Micro Infusion Sleeves
Alcon Laboratories, Inc.
00380650003379
In Commercial Distribution

  • 10380650003376 ()
  • 00380650003379 ()
8065000337

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

UNITY - 00380650003362

UNITY Cataract FMS Pack, 45° Balanced Tip with Micro Infusion Sleeves
Alcon Laboratories, Inc.
00380650003362
In Commercial Distribution

  • 10380650003369 ()
  • 00380650003362 ()
8065000336

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

UNITY - 00380650003355

UNITY Cataract FMS Pack, 30° Balanced Tip with Micro Infusion Sleeves
Alcon Laboratories, Inc.
00380650003355
In Commercial Distribution

  • 10380650003352 ()
  • 00380650003355 ()
8065000335

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

UNITY - 00380650003348

27+ UNITY TOTALPLUS Posterior Pack, UES HyperVit 30K DS, WA DS
Alcon Laboratories, Inc.
00380650003348
In Commercial Distribution

  • 10380650003345 ()
  • 00380650003348 ()
8065000334

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

UNITY - 00380650003324

25+ UNITY TOTALPLUS Posterior Pack, UES Short, UltraVit 10K Short, STD
Alcon Laboratories, Inc.
00380650003324
In Commercial Distribution

  • 10380650003321 ()
  • 00380650003324 ()
8065000332

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

UNITY - 00380650003317

25+ UNITY TOTALPLUS™ Posterior Pack, UES HyperVit 30K, Straight
Alcon Laboratories, Inc.
00380650003317
In Commercial Distribution

  • 10380650003314 ()
  • 00380650003317 ()
8065000331

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

UNITY - 00380650003300

25+ UNITY TOTALPLUS™ Posterior Pack, CVS ES UltraVit™ 10K, Straight
Alcon Laboratories, Inc.
00380650003300
In Commercial Distribution

  • 10380650003307 ()
  • 00380650003300 ()
8065000330

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

UNITY - 00380650003294

23Ga UNITY TOTALPLUS™ Posterior Pack, CVS ES UltraVit™ 10K, Straight
Alcon Laboratories, Inc.
00380650003294
In Commercial Distribution

  • 10380650003291 ()
  • 00380650003294 ()
8065000329

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

UNITY - 00380650003232

UNITY Cataract FMS Pack, Tipless with Nano Infusion Sleeves
Alcon Laboratories, Inc.
00380650003232
In Commercial Distribution

  • 10380650003239 ()
  • 00380650003232 ()
8065000323

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

UNITY - 00380650003225

UNITY Cataract FMS Pack, Tipless with Ultra Infusion Sleeves
Alcon Laboratories, Inc.
00380650003225
In Commercial Distribution

  • 10380650003222 ()
  • 00380650003225 ()
8065000322

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

UNITY - 00380650003218

UNITY Cataract FMS Pack, Tipless with Micro Infusion Sleeves
Alcon Laboratories, Inc.
00380650003218
In Commercial Distribution

  • 10380650003215 ()
  • 00380650003218 ()
8065000321

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

UNITY - 00380650003201

UNITY Cataract FMS Pack, Basic
Alcon Laboratories, Inc.
00380650003201
In Commercial Distribution

  • 10380650003208 ()
  • 00380650003201 ()
8065000320

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

UNITY - 00380650003157

UNITY U/S HP
Alcon Laboratories, Inc.
00380650003157
In Commercial Distribution

  • 00380650003157 ()
8065000315

  • Phacoemulsification system handpiece

UNITY - 00380650002969

UNITY VCS System (Anterior/Posterior)
Alcon Laboratories, Inc.
00380650002969
In Commercial Distribution

  • 00380650002969 ()
806500296

  • Phacoemulsification/vitrectomy system

UNITY - 00380650002501

27+ DS 30k Vit Probe
Alcon Laboratories, Inc.
00380650002501
In Commercial Distribution

  • 10380650002508 ()
  • 00380650002501 ()

  • 27 Gauge
8065000250

  • Vitrectomy system micro-cutting unit

UNITY - 00380650002433

LASER KIT
Alcon Laboratories, Inc.
00380650002433
In Commercial Distribution

  • 00380650002433 ()
8065000243

  • Phacoemulsification/vitrectomy system

UNITY TETRASPOT - 00380650002372

27GA TETRASPOT MultiSpot Laser Probe
Alcon Laboratories, Inc.
00380650002372
In Commercial Distribution

  • 10380650002379 ()
  • 00380650002372 ()

  • 27 Gauge
8065000237

  • Ophthalmic laser system beam guide

UNITY TETRASPOT - 00380650002365

25GA TETRASPOT MultiSpot Laser Probe
Alcon Laboratories, Inc.
00380650002365
In Commercial Distribution

  • 10380650002362 ()
  • 00380650002365 ()

  • 25 Gauge
8065000236

  • Ophthalmic laser system beam guide

UNITY - 00380650002150

OZIL Fragmentation Handpiece
Alcon Laboratories, Inc.
00380650002150
In Commercial Distribution

  • 00380650002150 ()
8065000215

  • Vitrectomy system handpiece

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

Ngenuity - 00380650001139

Microsurgical Camera
Alcon Laboratories, Inc.
00380650001139
In Commercial Distribution

  • 00380650001139 ()


  • Microscope video camera
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