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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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HEALICOIL REGENESORB 4.75 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE BLUE AND ONE No.2 ULTRABRAID SUTURE
Smith & Nephew, Inc.
72203705
In Commercial Distribution

  • 00885554031409 ()
72203705

  • Tendon/ligament bone anchor, bioabsorbable
One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-M50C
Not in Commercial Distribution

  • 10816203022469 ()
  • 20816203022466 ()


  • Blood transfer set
One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-M50
In Commercial Distribution

  • 20816203020264 ()
  • 10816203020267 ()


  • Blood transfer set
One spike to one male luer with 10cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-M10
Not in Commercial Distribution

  • 10816203020250 ()
  • 20816203020257 ()


  • Blood transfer set
One spike to one female luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F50
In Commercial Distribution

  • 10816203020243 ()
  • 20816203020240 ()


  • Blood transfer set
One spike to one female luer with 10cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F10
In Commercial Distribution

  • 10816203020236 ()
  • 20816203020233 ()


  • Blood transfer set
One spike to one female luer with 15cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F15
Not in Commercial Distribution

  • 10816203021929 ()
  • 20816203021926 ()


  • Blood transfer set
Two 15cm, tapered, carotid shunts. One 1408 shunt (14 Fr. to 8 Fr.) and one 1209 shunt (12 Fr. to 9 Fr.), together in one peel pack
Implantable Devices
Twin Pack
Not in Commercial Distribution

  • 00858764006185 ()
Twin Pack

  • Carotid artery shunt
Thrombin JMI - 5,000 IU Epistaxis Kit w/5 mL diluent; Contents - Sterile unless tray is opened or damaged: one vial 5,000 units thrombin, one vial 5 mL diluent, one sterile disposable syringe, one nasal drug delivery device
Pfizer H.C.P. Corporation
NDC 60793-205-05
In Commercial Distribution

  • 10360793205059 ()

  • Total Volume: 10 Milliliter
  • Syringe size


  • General surgical procedure kit, medicated
The Aspirex™ S Thrombectomy Catheter Set is composed of one Aspirex™ S Thrombectomy Catheter (gauge 6F; length 110cm), one Aspirex™ S Guidewire (0.018” diameter; 270cm in length), one collecting bag, and one sterile drape.
Straub Medical AG
80324
In Commercial Distribution

  • 07640142811312 ()

  • Catheter Gauge: 6 French
  • Catheter Working Length: 110 Centimeter
80324

  • Thrombectomy rotational catheter
Hand Tool #12 Driver for 3.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.12
In Commercial Distribution

  • 00083208120046 ()

  • Hand tool #12 Driver for 3.0mm one piece Implants (CB)
HT.12

  • Dental implant system
Hand Tool #25 Driver for 8.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.25
In Commercial Distribution

  • 00083208250040 ()

  • Hand Tool #25 Driver for 8.0mm one piece Implant (CB)
HT.25

  • Dental implant system
Hand Tool #24 Driver for 7.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.24
In Commercial Distribution

  • 00083208240041 ()

  • Hand Tool #24 Driver for 7.0mm one piece Implant (CB)
HT.24

  • Dental implant system
Hand Tool #23 Driver for 6.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.23
In Commercial Distribution

  • 00083208230042 ()

  • Hand Tool #23 Driver for 6.0mm one piece Implant (CB)
HT.23

  • Dental implant system
Hand Tool #18 Driver for 5.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.18
In Commercial Distribution

  • 00083208180040 ()

  • Hand tool #18 Driver for 5.0mm one piece Implants (CB)
HT.18

  • Dental implant system
Hand Tool #17 Driver for 4.0 and 4.5mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.17
In Commercial Distribution

  • 00083208170041 ()

  • Hand tool #17 Driver for 4.0-4.5mm one piece Implants (CB)
HT.17

  • Dental implant system
Hand Tool #15 Driver for 3.5mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.15
In Commercial Distribution

  • 00083208150043 ()

  • Hand tool #15 Driver for 3.5mm one piece Implants (CB)
HT.15

  • Dental implant system
Thrombin JMI - 5,000 IU Vial Syringe Spray Kit w/5 mL diluent; Contents - Sterile unless tray is opened or damaged: One vial 5,000 units thrombin, one vial 5 mL diluent, one sterile disposable syringe, one sterile spray tip.
Pfizer H.C.P. Corporation
NDC 60793-705-05
In Commercial Distribution

  • 10360793705054 ()

  • Syringe size
  • Total Volume: 10 Milliliter


  • General surgical procedure kit, medicated
Thrombin JMI - 20,000 IU Vial Syringe Spray Kit w/20 mL diluent; Contents - Sterile unless tray is opened or damaged: One vial 20,000 units thrombin, one vial 20 mL diluent, one sterile disposable syringe, one sterile spray tip.
Pfizer H.C.P. Corporation
NDC 60793-217-22
In Commercial Distribution

  • 10360793217229 ()

  • Syringe size
  • Total Volume: 20 Milliliter


  • General surgical procedure kit, medicated
Thrombin JMI - 20,000 IU Vial Pump spray Kit w/20 mL diluent; Contents - Sterile unless tray is opened or damaged: One vial 20,000 units thrombin, one vial 20 mL diluent, one spray pump and actuator, one transfer device.
Pfizer H.C.P. Corporation
NDC 60793-217-21
In Commercial Distribution

  • 10360793217212 ()

  • Total Volume: 20 Milliliter
  • Syringe size


  • General surgical procedure kit, medicated
XL Condom samplers 96 ct. List of Condoms in the bag: Trojan Magnum, Trustex Extra large, One legend XL, Cautionwear Grand Large (CW1000GR), Atlas XL, Lifestyles Large (A9800C), My One 60H, My One 57 G, My One 64J,
GLOBAL PROTECTION CORP.
BSC03096
In Commercial Distribution

  • 20726893112807 ()
  • 00726893112803 ()
  • 80726893112809 ()


  • Basic male condom, Hevea-latex
Integra® Jarit® Cottle Mallet, 7", 1-1/8"Diameter, Black Aluminum Handle, One Flat, One Round Face
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
410335
In Commercial Distribution

  • M2744103351 ()
  • 10381780456483 ()
410-335

  • Surgical mallet
LacriCATH kit DCP315-BIT contains two lacrimal duct catheters (3 mm), one AQL1015 inflation device, and one K12-01811 stopcock.
QUEST MEDICAL INC
DCP315-BIT
In Commercial Distribution

  • 20634624438327 ()


  • Lacrimal intubation set
Contains one (1) 120 gram powder (Clear), two (2) 60 milliliter liquids, and one (1) 30 milliliter sealer
Dentsply International Inc.
Soft Denture Liner 120 G Kit Clear
Not in Commercial Distribution

  • D001N8121000 ()
N812100

  • Dental appliance fabrication material, resin
Contains one (1) 120 gram powder (Pink), two (2) 60 milliliter liquids, and one (1) 30 milliliter sealer
Dentsply International Inc.
Soft Denture Liner 120 G Kit Pink
Not in Commercial Distribution

  • D001N8120000 ()
N812000

  • Dental appliance fabrication material, resin
Affinity COTTLE MALLET ONE FLAT FACE, ONE ROUND FACE FACE 28.6MM DIAMETER OVERALL LENGTH 7-7/8 inches 20CM
STERIS CORPORATION
RA1540
In Commercial Distribution

  • 10885403106316 ()
RA1540

  • Surgical mallet
AirLife™ Corrugated Tubing Connector One End Tappered, One End Straight Will Accept 22 mm I.D. Cuff Tubing
AIRLIFE
001823
In Commercial Distribution

  • 30889483570665 ()
  • 10889483570661 ()
001823

  • Straight/elbow breathing circuit connector, single-use
L&K Biomed Side Click Connector, One by one L:22, W:8, D1:6.5,D2:6.5 1EA
L&K BIOMED CO. ,LTD.
1812-6565
In Commercial Distribution

  • 08806189863922 ()
1812-6565

  • Bone-screw internal spinal fixation system connector
L&K Biomed Side Click Connector, One by one L:22, W:8, D1:6.2,D2:6.5 1EA
L&K BIOMED CO. ,LTD.
1812-6265
In Commercial Distribution

  • 08806189863915 ()
1812-6265

  • Bone-screw internal spinal fixation system connector
L&K Biomed Side Click Connector, One by one L:22, W:8, D1:6.2,D2:6.2 1EA
L&K BIOMED CO. ,LTD.
1812-6262
In Commercial Distribution

  • 08806189863908 ()
1812-6262

  • Bone-screw internal spinal fixation system connector
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