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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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DenFil - 08809254450065

Resin-based dental restorative material ; DenFil B2 4g x 1 syringe
VERICOM CO., LTD.
DF104-RB22
In Commercial Distribution

  • 08809254450065 ()


  • Dental composite resin

DenFil Flow - 08800123811574

Light-Cured Radiopaque Flowable Composite Resin ; DenFil Flow A3 0.5g x 1 syringe, 3 Disposable tips
VERICOM CO., LTD.
FR102-SA33
In Commercial Distribution

  • 08800123811574 ()


  • Dental composite resin

InfiltraLong set consisting of: - 14048223016692

InfiltraLong set consisting of: InfiltraLong catheter 19G x 900mm with integrated metal spiral with 88 drill
Pajunk GmbH Medizintechnologie
001158-40C
Not in Commercial Distribution

  • 14048223016692 ()
  • 04048223016695 ()
001158-40C

  • Peripheral anaesthesia catheter set, non-medicated

Rumex - 00840159905029

Gills-Vannas Capsulotomy Scissors, Straight, Sharp Tips, 10.00 mm Blades, Flat Handle, Length 88 mm, Stainless Steel
RUMEX INTERNATIONAL CORP.
11-056S
In Commercial Distribution

  • 00840159905029 ()
11-056S

  • Intraocular scissors, probe-like, reusable

Rumex - 00840159900901

Gills-Vannas Capsulotomy Scissors, Curved, Sharp Tips, 10.00 mm Blades, Flat Handle, Length 88 mm, Stainless Steel
RUMEX INTERNATIONAL CORP.
11-058S
In Commercial Distribution

  • 00840159900901 ()
11-058S

  • Intraocular scissors, probe-like, reusable

CVS Health - 00050428619087

Waterproof Adhesive Pad, all one size, 3.5 IN x 4.5 IN (88 mm x 114 mm)
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
397239
In Commercial Distribution

  • 20050428619081 ()
  • 00050428619087 ()
  • 60050428619089 ()


  • Adhesive bandage

K-2oem ALT-AIRE+ - 00817012022353

On-Demand Low Air loss Expandable mattress system, 80"-84"-88" x 36"-42"-48" x 10"
KAP MEDICAL
U-K-2oemXMS
In Commercial Distribution

  • 00817012022353 ()
U-K-2oemXMS

  • Low-air-loss bed

K-6 TURN-ZONE - 00817012022308

Alternating Pressure Lateral Rotation Expandable Mattress System, 80"-84"-88" x 36"-42"-48" x 10"
KAP MEDICAL
U-K-6XMS
In Commercial Distribution

  • 00817012022308 ()
U-K-6XMS

  • Low-air-loss bed

K-2oem ALT-AIRE+ - 00817012022193

On-Demand Low Air Loss Expandable Mattress System, 80"-84"-88" x 36"~39-42"-48" x 10"
KAP MEDICAL
K-2oemXMS
In Commercial Distribution

  • 00817012022193 ()
K-2oemXMS

  • Low-air-loss bed

Halyard - 30680651423024

Standard Back Table Cover, Fan Fold, 88 in. x 44 in. / 224 cm x 112 cm
O&M HALYARD, INC.
42302
In Commercial Distribution

  • 90680651423026 ()
  • 30680651423024 ()
42302NS

  • Medical equipment/instrument drape, single-use

Eagle Eyes - 00810712013492

STARR CO SET TORT/DEPO_GLD CO- Frame Material: TR-90 / Metal - Rectangle Office Wear /Gold Frame Clip On - Lens Technology: Base: DigiTec® Clip: TriLenium® 7 Polarized lens- Sunglasses
Eagle Eyes
22016
In Commercial Distribution

  • 00810712013492 ()
22016

  • Tinted non-prescription spectacle lens

Standard Supreme Drape - 00634916005363

SPINAL SHEET W/QCM 3 SPECIAL - 34X34 1PLY STD SUP W/REIN CO
STANDARD TEXTILE CO., INC.
95280252
In Commercial Distribution

  • 00634916005363 ()
  • 10634916005360 ()
95280252

  • Patient surgical drape, reusable

LIFEPAK 35 Monitor/Defibrillator - 00883873766279

LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873766279 ()
70335-000035

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765685

LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873765685 ()
70335-000037

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765678

LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873765678 ()
70335-000038

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765654

LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873765654 ()
70335-000039

  • Physiologic-monitoring defibrillation system

LIFEPAK 35 Monitor/Defibrillator - 00883873765616

LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN,STD,BT
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873765616 ()
70335-000042

  • Physiologic-monitoring defibrillation system

Surgical Direct - B382SD89909000

5mm Maryland Dissector, Curved, Diamond Serrated, Double Action Standard Length, with Non-Locking Co
Surgical Direct, Inc.
SD8990-900
In Commercial Distribution

  • B382SD89909000 ()
SD8990-900

  • Laparoscopic tissue manipulation forceps/working-channel

MSI Precision Specialty Instruments - 00194613105228

Air Injection Cannula, 27 Gauge, Angled 90 Degrees Shaft, 2.5mm From Tip To Bend, With Polished Finish, And Excluding Hub Overall Length Of 3/4"(19mm)
Med Saver, Inc.
5-1500-27-25-90
In Commercial Distribution

  • 00194613105228 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MSI Precision Specialty Instruments - 00194613101381

Air Injection Cannula, 27 Gauge, Angled 90 Degrees Shaft, 1.0mm From Tip To Bend, With Polished Finish, And Excluding Hub Overall Length Of 3/4"(19mm)
Med Saver, Inc.
5-1500-27-1-90
In Commercial Distribution

  • 00194613101381 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MSI Precision Specialty Instruments - 00194613064136

Air Injection Cannula, 27 Gauge, Angled 90 Degrees Shaft, 3mm From Tip To Bend, With Polished Finish, And Excluding Hub Overall Length Of 3/4"(19mm)
Med Saver, Inc.
5-1500-27-3-90
In Commercial Distribution

  • 00194613064136 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MSI Precision Specialty Instruments - 00194613064129

Air Injection Cannula, 27 Gauge, Angled 90 Degrees Shaft, 1.5mm From Tip To Bend, With Polished Finish, And Excluding Hub Overall Length Of 3/4"(19mm)
Med Saver, Inc.
5-1500-27-15-90
In Commercial Distribution

  • 00194613064129 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

SGP 3 - 00830002003019

Blanks (button blanks for use in the manufacture of RGP contact lenses) Color: Blue, Green, or Clear Number of Units
LIFESTYLE CO INC, THE
unifocon A
In Commercial Distribution

  • 00830002003019 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear

ASI INSTRUMENTSMEDIAL CALCAR STYLE RETRACTOR - 05019279998364

No Description
Biomet Uk Ltd
110028568
In Commercial Distribution

  • 05019279998364 ()

  • NUMBER 5B
110028568

  • Hand-held surgical retractor, reusable

ASI INSTRUMENTSMEDIAL CALCAR STYLE RETRACTOR - 05019279998357

No Description
Biomet Uk Ltd
110028567
In Commercial Distribution

  • 05019279998357 ()

  • NUMBER 5A
110028567

  • Hand-held surgical retractor, reusable

ASI INSTRUMENTSFEMORAL ELEVATOR RETRACTOR - 05019279998340

No Description
Biomet Uk Ltd
110028566
In Commercial Distribution

  • 05019279998340 ()

  • NUMBER 4
110028566

  • Hand-held surgical retractor, reusable

ASI INSTRUMENTSPOSTERIOR ACETABULAR RETRACTOR - 05019279998333

No Description
Biomet Uk Ltd
110028565
In Commercial Distribution

  • 05019279998333 ()

  • NUMBER 3
110028565

  • Hand-held surgical retractor, reusable

ASI INSTRUMENTSACETABULAR RETRACTOR - 05019279998326

No Description
Biomet Uk Ltd
110028564
In Commercial Distribution

  • 05019279998326 ()

  • NUMBER 2
110028564

  • Hand-held surgical retractor, reusable

ASI INSTRUMENTSCOBRA STYLE RETRACTOR - 05019279998319

No Description
Biomet Uk Ltd
110028563
In Commercial Distribution

  • 05019279998319 ()

  • NUMBER 1
110028563

  • Hand-held surgical retractor, reusable

B Medical Systems - 05450104551512

Ultra Low Freezer
B Medical Systems SARL
U201
In Commercial Distribution

  • 05450104551512 ()
991.8643.**

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104543920

Ultra Low Freezer
B Medical Systems SARL
U401
In Commercial Distribution

  • 05450104543920 ()
991.8603.**

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104543906

Ultra Low Freezer
B Medical Systems SARL
U501
In Commercial Distribution

  • 05450104543906 ()
991.8613.**

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104543883

Ultra Low Freezer
B Medical Systems SARL
U701
In Commercial Distribution

  • 05450104543883 ()
991.8623.**

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104543869

Ultra Low Freezer
B Medical Systems SARL
U901
In Commercial Distribution

  • 05450104543869 ()
991.8633.**

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104539077

Ultra Low Freezer
B Medical Systems SARL
U401
Not in Commercial Distribution

  • 05450104539077 ()
991.8603.01

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104539060

Ultra Low Freezer
B Medical Systems SARL
U501
In Commercial Distribution

  • 05450104539060 ()
991.8613.01

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104539053

Ultra Low Freezer
B Medical Systems SARL
U901
Not in Commercial Distribution

  • 05450104539053 ()
991.8633.01

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104538988

Ultra Low Freezer
B Medical Systems SARL
U701
Not in Commercial Distribution

  • 05450104538988 ()
991.8623.01

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104533488

Ultra Low Freezer
B Medical Systems SARL
UF755G
Not in Commercial Distribution

  • 05450104533488 ()
991.7056.51

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104533471

Ultra Low Freezer
B Medical Systems SARL
UF455G
Not in Commercial Distribution

  • 05450104533471 ()
991.7046.51

  • Ultralow-temperature laboratory freezer
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