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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DRIVER 9010009005 ONE SIDE SWIZZLE STICK
MEDTRONIC SOFAMOR DANEK, INC.
9010009005
In Commercial Distribution

  • 00763000218256 ()


  • Orthopaedic implant driver
3.5MM HEX HEAD SCREWDRIVER ONE PIECE
Smith & Nephew, Inc.
E0017884-1
In Commercial Distribution

  • 00885556889688 ()
E0017884-1

  • Surgical screwdriver, reusable
Hp One Way Stopcock W/Ra500C
DEROYAL INDUSTRIES, INC.
35-400756
In Commercial Distribution

  • 50749756664757 ()
  • 00749756664752 ()


  • Angiography kit
ONE THIRD TUBULAR PLATE - 8 HOLE
Smith & Nephew, Inc.
2813008
In Commercial Distribution

  • 00885556838556 ()
2813008

  • Orthopaedic fixation plate, non-bioabsorbable
ONE THIRD TUBULAR PLATE - 6 HOLE
Smith & Nephew, Inc.
2813006
In Commercial Distribution

  • 00885556838549 ()
2813006

  • Orthopaedic fixation plate, non-bioabsorbable
ONE THIRD TUBULAR PLATE - 4 HOLE
Smith & Nephew, Inc.
2813004
In Commercial Distribution

  • 00885556838532 ()
2813004

  • Orthopaedic fixation plate, non-bioabsorbable
LMP SYSTEM PROXIMAL BROACH. ONE SIZE
Smith & Nephew, Inc.
LMP-PST
In Commercial Distribution

  • 00885556834626 ()
LMP-PST

  • Orthopaedic broach
LMP SYSTEM DISTAL BROACH. ONE SIZE
Smith & Nephew, Inc.
LMP-DST
In Commercial Distribution

  • 00885556834602 ()
LMP-DST

  • Orthopaedic broach
Monitor with one blood parameter module.
Terumo Cardiovascular Systems Corporation
500A
In Commercial Distribution

  • 00886799001615 ()
500A

  • Extracorporeal blood gas/pH monitor
Mesh Gauze One Plus 17 PLY
DEROYAL INDUSTRIES, INC.
10-5510
In Commercial Distribution

  • 50749756038718 ()
  • 00749756038713 ()
10-5510

  • Wound-nonadherent dressing, permeable, non-antimicrobial
Mesh Gauze One Plus 6 PLY
DEROYAL INDUSTRIES, INC.
10-5500
In Commercial Distribution

  • 50749756038572 ()
  • 00749756038577 ()
  • 10749756038574 ()
10-5500

  • Wound-nonadherent dressing, permeable, non-antimicrobial
One Side Perforated ExtraFineDiamond Strip 3.75
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
OSP-37XF-01
In Commercial Distribution

  • 17291046701000 ()
OSP-37XF

  • Dental abrasive strip, reusable
Gown_Set-In sleeve_Standard_W/ one hand towel_Small_Non-sterile_40ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300467
In Commercial Distribution

  • 06931918178328 ()
  • 16931918178325 ()


  • Surgical gown, single-use
Gown_Set-In sleeve_Standard_Large_W/ one hand towel_Sterile_20ea/cs
GRI Medical & Electronic Technology Co., Ltd.
92-4020-S1
In Commercial Distribution

  • 26931918177707 ()
  • 16931918177700 ()


  • Surgical gown, single-use
Surgical Gown_Non-Reinforced_W/ one hand towle_XXL_Non-Sterile_28ea/cs
GRI Medical & Electronic Technology Co., Ltd.
60300457
In Commercial Distribution

  • 06931918198456 ()
  • 16931918198453 ()


  • Surgical gown, single-use
Surgical Gown_i500_Non-Reinforced_L_W/ one hand towel_Sterile_30EA/CS
GRI Medical & Electronic Technology Co., Ltd.
i90-8020-S1
In Commercial Distribution

  • 26931918168347 ()
  • 16931918168340 ()


  • Surgical gown, single-use
Crib Bed 35x76 One Drop Side
PEDICRAFT, INC.
34721
In Commercial Distribution

  • 00766923347218 ()
34721

  • Paediatric bed
Surgical Gown_Non-Reinforced_L_W/ one hand towel_Sterile_30EA/CS
GRI Medical & Electronic Technology Co., Ltd.
GH90-8020-S1
In Commercial Distribution

  • 26931918196432 ()
  • 16931918196435 ()


  • Surgical gown, single-use
Surgical Gown_i500_Non-Reinforced_L_W/ one hand towel_Sterile_30EA/CS
GRI Medical & Electronic Technology Co., Ltd.
SF90-8020-S1
In Commercial Distribution

  • 26931918178995 ()
  • 16931918178998 ()


  • Surgical gown, single-use
Crestone One Piece Implant ø3.50 L16mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140689 ()
IC1-35016

  • Dental implant system
Crestone One Piece Implant ø3.50 L13mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140672 ()
IC1-35013

  • Dental implant system
Crestone One Piece Implant ø3.5 L11.5mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140665 ()
IC1-35011

  • Dental implant system
Crestone One Piece Implant ø3.50 L10mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140658 ()
IC1-35010

  • Dental implant system
Crestone One Piece Implant ø3 L16mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140641 ()
IC1-30016

  • Dental implant system
Crestone One Piece Implant ø3 L13mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140634 ()
IC1-30013

  • Dental implant system
Crestone One Piece Implant ø3 L11.50mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140627 ()
IC1-30011

  • Dental implant system
Crestone One Piece Implant ø3 L10mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140610 ()
IC1-30010

  • Dental implant system
One box with 2 vials strip
BIONIME CORPORATION
Max Strip
In Commercial Distribution

  • 20883489001744 ()
  • 10883489001747 ()
  • 00883489001740 ()
  • 00883489001733 ()
  • 80883489001739 ()


  • Glucose monitoring system IVD, home-use
Devon Magnetic Drape One Neutral Zone
Cardinal Health 200, LLC
31159703
In Commercial Distribution

  • 10192253021585 ()
  • 50192253021583 ()
31159703

  • Medical equipment/instrument drape, single-use
Reline One Power Instrument Set - Alpha
Nuvasive, Inc.
ALPRELONEPOWIN
In Commercial Distribution

  • 00195377098450 ()


  • Device sterilization/disinfection container, reusable
Alpha Reline One Polyaxial Imp Tray
Nuvasive, Inc.
ALPRELONEPOLY
In Commercial Distribution

  • 00195377050236 ()


  • Device sterilization/disinfection container, reusable
Alpha Reline One Modular Imp Tray
Nuvasive, Inc.
ALPRELONEMOD
In Commercial Distribution

  • 00195377050229 ()


  • Internal spinal fixation procedure kit, reusable
MOD-EX XLIF Inserter, All In One
Nuvasive, Inc.
D1970000
In Commercial Distribution

  • 00195377043511 ()


  • Internal spinal fixation procedure kit, reusable
Large Arm Calibrated V-Lok Cuff & Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1869MFCC
In Commercial Distribution

  • 00810010922649 ()
1869MFCC

  • Aneroid manual sphygmomanometer
Thigh Calibrated V-Lok Cuff & Non Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1884MFCCNL
In Commercial Distribution

  • 00810010922632 ()
1884MFCCNL

  • Aneroid manual sphygmomanometer
Infant Calibrated V-Lok Cuff & Non Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1882MFCCNL
In Commercial Distribution

  • 00810010922571 ()
1882MFCCNL

  • Aneroid manual sphygmomanometer
Child Calibrated V-Lok Cuff & Non Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1881MFCCNL
In Commercial Distribution

  • 00810010922533 ()
1881MFCCNL

  • Aneroid manual sphygmomanometer
Adult Calibrated V-Lok Cuff & Non Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1880MFCCNL
In Commercial Distribution

  • 00810010922519 ()
1880MFCCNL

  • Aneroid manual sphygmomanometer
Center piece, turquoise, Ø 13mm, height 19-27.5mm, one fixed end cap, one variable end cap
Ulrich Medical Usa, Inc.
UU041-01-1927
In Commercial Distribution

  • 00814386022293 ()
UU041-01-1927

  • Vertebral body prosthesis
Center piece, yellow, Ø 13mm, height 16-21.5mm, one fixed end cap, one variable end cap
Ulrich Medical Usa, Inc.
UU041-01-1621
In Commercial Distribution

  • 00814386022286 ()
UU041-01-1621

  • Vertebral body prosthesis
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
8F; 90 cm; straight
In Commercial Distribution

  • 14251244503847 ()
  • 04251244503840 ()

  • Length: 90 Centimeter
  • Lumen/Inner Diameter: 2.88 Millimeter
452389

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
8F; 45 cm; straight
In Commercial Distribution

  • 14251244503809 ()
  • 04251244503802 ()

  • Length: 45 Centimeter
  • Lumen/Inner Diameter: 2.88 Millimeter
452385

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
7F; 90 cm; straight
In Commercial Distribution

  • 14251244503793 ()
  • 04251244503796 ()

  • Length: 90 Centimeter
  • Lumen/Inner Diameter: 2.55 Millimeter
452388

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
4F; 65 cm; straight
In Commercial Distribution

  • 14251244503632 ()
  • 04251244503635 ()

  • Lumen/Inner Diameter: 1.62 Millimeter
  • Length: 65 Centimeter
444486

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
8F, 65cm, straight
In Commercial Distribution

  • 14251244500952 ()
  • 04251244500955 ()

  • Length: 65 Centimeter
  • Lumen/Inner Diameter: 2.88 Millimeter
452384

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
8F, 45cm, Crossover
In Commercial Distribution

  • 14251244500945 ()
  • 04251244500948 ()

  • Length: 45 Centimeter
  • Lumen/Inner Diameter: 2.88 Millimeter
452387

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
8F, 45cm, Straight
In Commercial Distribution

  • 14251244500921 ()
  • 04251244500924 ()

  • Length: 45 Centimeter
  • Lumen/Inner Diameter: 2.88 Millimeter
452385

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
7F, 65cm, straight
In Commercial Distribution

  • 04251244500917 ()
  • 14251244500914 ()

  • Length: 65 Centimeter
  • Lumen/Inner Diameter: 2.55 Millimeter
452383

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
7F, 45cm, Straight
In Commercial Distribution

  • 04251244500887 ()
  • 14251244500884 ()

  • Length: 45 Centimeter
  • Lumen/Inner Diameter: 2.55 Millimeter
452382

  • Vascular catheter introduction set, nonimplantable
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Contract Medical International GmbH
8F, 45cm, straigth, firm
In Commercial Distribution

  • 14251244500839 ()
  • 04251244500832 ()
  • 24251244500836 ()

  • Length: 45 Centimeter
  • Lumen/Inner Diameter: 2.88 Millimeter
FG-08045-F

  • Vascular catheter introduction set, nonimplantable
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