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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DD450 High Frequency Headset CH Din 8 Pins + Mini 4Pins male connector
Interacoustics A/S
DD450 High Frequency Headset CH
In Commercial Distribution

  • 05711117243734 ()


  • Earphone, circumaural
DD450 High Frequency Headset CH 30° 6.3mm x2 2Poles Mini 4Pins male connector
Interacoustics A/S
DD450 High Frequency Headset CH
In Commercial Distribution

  • 05711117243727 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65v2
In Commercial Distribution

  • 05711117228847 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65v2
In Commercial Distribution

  • 05711117228830 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65v2
In Commercial Distribution

  • 05711117228823 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65v2
In Commercial Distribution

  • 05711117228816 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65v2
In Commercial Distribution

  • 05711117228809 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65v2
In Commercial Distribution

  • 05711117228793 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65v2
In Commercial Distribution

  • 05711117228786 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65v2
In Commercial Distribution

  • 05711117228779 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD450
In Commercial Distribution

  • 05711117228762 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD450
In Commercial Distribution

  • 05711117228755 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD450
In Commercial Distribution

  • 05711117228748 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD450
In Commercial Distribution

  • 05711117228731 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD450
In Commercial Distribution

  • 05711117228724 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD450
In Commercial Distribution

  • 05711117228717 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65
In Commercial Distribution

  • 05711117222036 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65
In Commercial Distribution

  • 05711117221442 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65v2
In Commercial Distribution

  • 05711117221435 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65
In Commercial Distribution

  • 05711117219609 ()


  • Earphone, circumaural
No Description
Interacoustics A/S
DD65
In Commercial Distribution

  • 05711117219531 ()


  • Earphone, circumaural
No Description
BIOMET SPINE LLC
6602
In Commercial Distribution

  • 00888480403579 ()

  • TAPER POINT EXTERNAL HEX SET SCREW (TI)
6602

  • Orthopaedic surgical procedure kit, non-medicated, reusable
BARD® BURBANK™ Carotid Bypass Shunt, 18F - 12F x 15.5cm
Bard Peripheral Vascular, Inc.
SGA162001
Not in Commercial Distribution

  • 10801741090230 ()
  • 00801741090233 ()

  • Length: 15.5 Centimeter
  • External Diameter - 18 French to 12 French
SGA162001

  • Carotid artery shunt
BARD® JAVID™ Carotid Bypass Shunt, 14F - 8F x 13cm
Bard Peripheral Vascular, Inc.
SGA155001
Not in Commercial Distribution

  • 10801741090223 ()
  • 00801741090226 ()

  • Length: 13 Centimeter
  • External Diameter - 14 French to 8 French
SGA155001

  • Carotid artery shunt
BARD® BURBANK™ Carotid Bypass Shunt, 12F - 9F x 15.5cm
Bard Peripheral Vascular, Inc.
SGA150001
Not in Commercial Distribution

  • 10801741090216 ()
  • 00801741090219 ()

  • Length: 15.5 Centimeter
  • External Diameter - 12 French to 9 French
SGA150001

  • Carotid artery shunt
BARD® BURBANK™ Carotid Bypass Shunt, 15F - 10F x 15.5cm
Bard Peripheral Vascular, Inc.
SGA149001
Not in Commercial Distribution

  • 10801741090209 ()
  • 00801741090202 ()

  • Length: 15.5 Centimeter
  • External Diameter - 15 French to 10 French
SGA149001

  • Carotid artery shunt
BARD® BRENER™ Carotid Bypass Shunt, Tapered Carotid Shunt With Side Arm, 17F - 10F x 13cm
Bard Peripheral Vascular, Inc.
S11887002
Not in Commercial Distribution

  • 10801741090193 ()
  • 00801741090196 ()

  • External Diameter - 17 French to 10 French
  • Length: 13 Centimeter
S11887002

  • Carotid artery shunt
BARD® BRENER™ Carotid Bypass Shunt, Tapered Carotid Shunt With Side Arm, 14F-8F x 13cm
Bard Peripheral Vascular, Inc.
007755
Not in Commercial Distribution

  • 10801741090124 ()
  • 00801741090127 ()

  • External Diameter - 14 French to 8 French
  • Length: 13 Centimeter
007755

  • Carotid artery shunt
BARD® JAVID™ Carotid Bypass Shunt, 17F - 10F x 27.5cm
Bard Peripheral Vascular, Inc.
007714
Not in Commercial Distribution

  • 10801741090117 ()
  • 00801741090110 ()

  • External Diameter - 17 French to 10 French
  • Length: 27.5 Centimeter
007714

  • Carotid artery shunt
cable splitter for external triggering af a MagPro slave device as well as an external device. Approved with MagPro R30 in K061645.
Tonica Elektronik A/S
Cable Splitter Ext. Trig for MagPro slave and Keypoint
In Commercial Distribution

  • 05713484030726 ()
9016E4581

  • Magnetic neural stimulation system
Integra® External Fixation System The pivoting socket wrench is used to tighten nuts and other parts in the external fixation system.
Ascension Orthopedics, Inc.
12224506
In Commercial Distribution

  • M269122245061 ()
  • 10381780248088 ()

  • 157.8 mm L; 10.03 mm opening
12224506

  • External orthopaedic fixation system, reusable
Pit & Fissure Sealant
DARBY DENTAL SUPPLY, LLC
SDSK
In Commercial Distribution

  • 10889813002695 ()
  • 00889813002698 ()

  • Total Volume: 1.2 Milliliter
9517515

  • Dental pit/fissure sealant
3 mL syringe -34.4% Filled
PULPDENT CORPORATION
SEAL3
In Commercial Distribution

  • D701SEAL32 ()

  • Total Volume: 3 Milliliter


  • Dental pit/fissure sealant
KIT: 4 x 1.2 mL syringes + 8 applicator tips, off-white 34.4% Filled
PULPDENT CORPORATION
SEAL
In Commercial Distribution

  • D701SEAL2 ()

  • Total Volume: 1.2 Milliliter


  • Dental pit/fissure sealant
Bulk Pack: 20 x 1.2 mL syringes, off white-shade shade + 100 applicator tips 36.6% filled
PULPDENT CORPORATION
EMSWB
In Commercial Distribution

  • D701EMSWB2 ()

  • Total Volume: 1.2 Milliliter


  • Dental pit/fissure sealant
Kit: 4 x 1.2 mL syringes sealant, off-white shade + 20 applicator tips 36.6% filled
PULPDENT CORPORATION
EMSW
In Commercial Distribution

  • D701EMSW2 ()

  • Total Volume: 1.2 Milliliter


  • Dental pit/fissure sealant
Bulk Pack: 20 x 1.2 mL syringes, natural shade + 100 applicator tips 36.6% filled
PULPDENT CORPORATION
EMSB
In Commercial Distribution

  • D701EMSB2 ()

  • Total Volume: 1.2 Milliliter


  • Dental pit/fissure sealant
3 mL syringe only, off-white shade 36.6% filled
PULPDENT CORPORATION
EMS3W
In Commercial Distribution

  • D701EMS3W2 ()

  • Total Volume: 3 Milliliter


  • Dental pit/fissure sealant
3 mL syringe only, natural shade 36.6% filled
PULPDENT CORPORATION
EMS3
In Commercial Distribution

  • D701EMS32 ()

  • Total Volume: 3 Milliliter


  • Dental pit/fissure sealant
PIT AND FISSURE SEALANT 36.6% FILLED Kit: 4 x 1.2 mL syringes sealant, natural shade + 20 applicator tips
PULPDENT CORPORATION
EMS
In Commercial Distribution

  • D701EMS2 ()

  • Total Volume: 1.2 Milliliter


  • Dental pit/fissure sealant
PIT & FISSURE SEALANT 3ML
DARBY DENTAL SUPPLY, LLC
SDSR
In Commercial Distribution

  • 00889813001714 ()

  • Total Volume: 3 Milliliter
9517517

  • Dental pit/fissure sealant
Pit & Fissure LC Sealant w Fluoride Sample
Harry J Bosworth Company
092156S
In Commercial Distribution

  • H668092156S1 ()

  • Total Volume: 1.2 Milliliter
092156S

  • Dental pit/fissure sealant
Aegis Pit & Fissure Sealant w/ACP 0.4 mL Sample
Harry J Bosworth Company
0921328S
In Commercial Distribution

  • H6680921328S1 ()

  • Total Volume: 0.4 Milliliter
0921328S

  • Dental pit/fissure sealant
Aegis Pit & Fissure Sealant w/ACP Clinic Kit
Harry J Bosworth Company
0921327
In Commercial Distribution

  • H66809213271 ()
  • H66809213270 ()

  • Total Volume: 1.2 Milliliter
0921327

  • Dental pit/fissure sealant
Pit & Fissure LC Sealant w Fluoride
Harry J Bosworth Company
092156
In Commercial Distribution

  • H6680921561 ()
  • H6680921560 ()

  • Total Volume: 1.2 Milliliter
092156

  • Dental pit/fissure sealant
Aegis Pit & Fissure Sealant w/ACP Standard Kit
Harry J Bosworth Company
0921348
In Commercial Distribution

  • H66809213481 ()

  • Total Volume: 1.2 Milliliter
0921348

  • Dental pit/fissure sealant
Aegis Pit & Fissure Sealant w/ACP Refill Kit
Harry J Bosworth Company
0921328
In Commercial Distribution

  • H66809213281 ()
  • H66809213280 ()

  • Total Volume: 1.2 Milliliter
0921328

  • Dental pit/fissure sealant
Natural Elegance Sealant
HENRY SCHEIN, INC.
1126407
In Commercial Distribution

  • 00304040007129 ()

  • Sealant Syringe x 4
  • Total Volume: 3 Milliliter
  • Weight: 1 Gram
  • Etchant Liquid
  • Needle Gauge: 22 Gauge
  • Syringe Tip x 6
1126407

  • Dental pit/fissure sealant
Natural Elegance Sealant
HENRY SCHEIN, INC.
9001004
In Commercial Distribution

  • 00304040007037 ()

  • Sealant Syringe x 4
  • Total Volume: 3 Milliliter
  • Etchant
  • Needle Gauge: 22 Gauge
  • Syringe Tip x 6
  • Weight: 1 Gram
9001004

  • Dental pit/fissure sealant
No Description
HUGH STEEPER LIMITED
Cosmetic Hand Right Male Adult - Long Fingers
In Commercial Distribution

  • 05055348280237 ()
FHL22

  • Passive hand prosthesis
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