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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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The clamp is used to secure the positioning of the plate onto the bone.
NEWDEAL
189201ND
Not in Commercial Distribution

  • M248189201ND1 ()
  • 10381780051886 ()


  • Implant handling forceps, scissors-like
The Modulare System is used to secure various types of catheters to the patient’s skin. The device uses a post and securement cover to attach itself to either the suture tab of the catheter or mating hole on Modulare accessories. An adhesive base secures the Modulare system to the patient to allow for safe and secure placement of the catheter onto the patient. The Modulare system is disposable and designed to be placed on the patient for a time to not to exceed 7 days.
INSIGHTRA MEDICAL, INC.
M-CVC/PICCSP
Not in Commercial Distribution

  • 00013964672275 ()
  • 00013964672237 ()
  • 00013964672268 ()
  • 00013964672251 ()
  • 00013964672244 ()


  • Wearable percutaneous catheter/tube holder
The Modulare System is used to secure various types of catheters to the patient’s skin. The device uses a post and securement cover to attach itself to either the suture tab of the catheter or mating hole on Modulare accessories. An adhesive base secures the Modulare system to the patient to allow for safe and secure placement of the catheter onto the patient. The Modulare system is disposable and designed to be placed on the patient for a time to not to exceed 7 days.
INSIGHTRA MEDICAL, INC.
M-CVC/PICC
Not in Commercial Distribution

  • 00013964672077 ()
  • 00013964672213 ()
  • 00013964672206 ()
  • 00013964672220 ()
  • 00013964672183 ()


  • Wearable percutaneous catheter/tube holder
The glenosphere inserter is used to insert the glenosphere into the baseplate.
Ascension Orthopedics, Inc.
HDL096006501
In Commercial Distribution

  • M269HDL0960065011 ()
  • 10381780237051 ()

  • 9.8 in L
HDL-0960-065-01

  • Orthopaedic inorganic implant inserter/extractor, reusable
The wedge 20° is used to adjust the orientation of the osteotomy
NEWDEAL
189220ND
Not in Commercial Distribution

  • M248189220ND1 ()
  • 10381780052944 ()

  • 20° large correction


  • Bone-angle protractor
The wedge 15° is used to adjust the orientation of the osteotomy
NEWDEAL
189215ND
Not in Commercial Distribution

  • M248189215ND1 ()
  • 10381780052937 ()

  • 15° medium correction


  • Bone-angle protractor
The wedge 10° is used to adjust the orientation of the osteotomy
NEWDEAL
189210ND
Not in Commercial Distribution

  • M248189210ND1 ()
  • 10381780052920 ()

  • 10° small correction


  • Bone-angle protractor
Connects the Guidance Handpiece to the Acessa Generator and the Guidance Controller.
HALT MEDICAL, INC
5400
In Commercial Distribution

  • 00854763006096 ()
5400

  • Electromagnetic surgical navigation device tracking system
The disposable Roth Net polyp retrieval device is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.
US Endoscopy
00711151
Not in Commercial Distribution

  • 10816765011253 ()
  • 00816765011256 ()

  • Width: 3 Centimeter
  • Length: 230 Centimeter
  • Outer Diameter: 2.5 Millimeter
00711151

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The disposable Roth Net polyp retrieval device is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.
US Endoscopy
00711150
Not in Commercial Distribution

  • 10816765011246 ()
  • 00816765011249 ()

  • Length: 230 Centimeter
  • Width: 3 Centimeter
  • Outer Diameter: 2.5 Millimeter
00711150

  • Gastrointestinal/airway foreign body retrieval basket, single-use
Polyp Retrieval Net, 3x6cm, 230cm
DIVERSATEK HEALTHCARE, INC.
1175-10
In Commercial Distribution

  • 10816734021382 ()
  • 00816734021385 ()

  • Width: 3 Centimeter
  • Depth: 6 Centimeter
  • Length: 230 Centimeter
1175-10

  • Gastrointestinal/airway foreign body retrieval basket, single-use
Standard Retrieval Net, 3x6cm, 230cm
DIVERSATEK HEALTHCARE, INC.
1175-01
In Commercial Distribution

  • 10816734021368 ()
  • 00816734021361 ()

  • Width: 3 Centimeter
  • Depth: 6 Centimeter
  • Length: 230 Centimeter
1175-01

  • Gastrointestinal/airway foreign body retrieval basket, single-use
Standard Retrieval Net, 3x6cm, 160cm
DIVERSATEK HEALTHCARE, INC.
1175-00
In Commercial Distribution

  • 10816734021351 ()
  • 00816734021354 ()

  • Length: 160 Centimeter
  • Depth: 6 Centimeter
  • Width: 3 Centimeter
1175-00

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The disposable Roth Net Platinum polyp, sterile retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.
US Endoscopy
00715160
Not in Commercial Distribution

  • 10816765012007 ()
  • 00816765012000 ()

  • Outer Diameter: 3 Millimeter
  • Length: 230 Centimeter
  • Width: 4 Centimeter
00715160

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The disposable Roth Net Platinum polyp retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.
US Endoscopy
00715150
Not in Commercial Distribution

  • 10816765011994 ()
  • 00816765011997 ()

  • Width: 4 Centimeter
  • Outer Diameter: 3 Millimeter
  • Length: 230 Centimeter
00715150

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The disposable Roth Net Platinum universal, sterile retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.
US Endoscopy
00715060
Not in Commercial Distribution

  • 10816765011987 ()
  • 00816765011980 ()

  • Width: 4 Centimeter
  • Outer Diameter: 2.5 Millimeter
  • Length: 230 Centimeter
00715060

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The disposable Roth Net Platinum universal retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.
US Endoscopy
00715050
Not in Commercial Distribution

  • 10816765011970 ()
  • 00816765011973 ()

  • Length: 230 Centimeter
  • Width: 4 Centimeter
  • Outer Diameter: 2.5 Millimeter
00715050

  • Gastrointestinal/airway foreign body retrieval basket, single-use
The disposable Roth Net Platinum food bolus retrieval device is used in the endoscopic retrieval food bolus.
US Endoscopy
00711155
Not in Commercial Distribution

  • 10816765011277 ()
  • 00816765011270 ()

  • Width: 4 Centimeter
  • Length: 160 Centimeter
  • Outer Diameter: 2.5 Millimeter
00711155

  • Gastrointestinal/airway foreign body retrieval basket, single-use
Endoscopic Retrieval Net - Maxi, Colonic
ENDO-THERAPEUTICS, INC.
ET2015
In Commercial Distribution

  • 10816207021123 ()
  • 00816207021126 ()

  • Net Size: 4.0 cm x 8.0 cm
  • Length: 230 Centimeter
  • Min. Channel 3.2 mm
  • Outer Diameter: 3.0 Millimeter
ET2015

  • Gastrointestinal/airway foreign body retrieval basket, single-use
Endoscopic Retrieval Net - Standard, Enteroscope
ENDO-THERAPEUTICS, INC.
ET2013
In Commercial Distribution

  • 10816207021109 ()
  • 00816207021102 ()

  • Net Size: 3.0 cm x 6.0 cm
  • Length: 350 Centimeter
  • Min. Channel 2.8 mm
  • Outer Diameter: 2.5 Millimeter
ET2013

  • Gastrointestinal/airway foreign body retrieval basket, single-use
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