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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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ABSORBENT POINTS (200/box) Type: ISO, Size: 60; For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9079
In Commercial Distribution

  • D77810390790 ()
  • D77810390791 ()
103-9079

  • Endodontic paper point
ABSORBENT POINTS (200/box) Type: ISO, Size: 50; For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9075
In Commercial Distribution

  • D77810390750 ()
  • D77810390751 ()
103-9075

  • Endodontic paper point
ABSORBENT POINTS (200/box) Type: ISO, Size: 40; For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9071
In Commercial Distribution

  • D77810390710 ()
  • D77810390711 ()
103-9071

  • Endodontic paper point
ABSORBENT POINTS (200/box) Type: ISO, Size: 35; For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9069
In Commercial Distribution

  • D77810390690 ()
  • D77810390691 ()
103-9069

  • Endodontic paper point
ABSORBENT POINTS (200/box) Type: ISO, Size: 25; For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9065
In Commercial Distribution

  • D77810390650 ()
  • D77810390651 ()
103-9065

  • Endodontic paper point
ABSORBENT POINTS (200/box) Type: ISO, Size: 15; For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9061
In Commercial Distribution

  • D77810390610 ()
  • D77810390611 ()
103-9061

  • Endodontic paper point
No Description
ALIMED, INC.
910398ZBW
In Commercial Distribution

  • 00733657259018 ()
2970011543

  • Operating table mattress, basic
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution

  • 00860003118313 ()


  • Medical networking interface unit
reSET-O® Mobile Application running on Android. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008187 ()


  • Mental health/function therapeutic software, screen-viewed
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008170 ()


  • Mental health/function therapeutic software, screen-viewed
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