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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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ENDODONTIC POSTS - D821033PSF9R0

SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis.
RHEIN 83 SRL
PIVOT FLEX mm.9
Not in Commercial Distribution

  • D821033PSF9R0 ()
033PSF9R

  • Dental implant suprastructure, permanent, preformed

DIRECT TITANIUM ATTACHMENTS - D821008MBGIQ0

Used for measuring the gingival cuff height in order to choose the correct height of the abutment.
RHEIN 83 SRL
CUFF HEIGHT MEASURING TOOL
Not in Commercial Distribution

  • D821008MBGIQ0 ()
008MBG-IQ

  • Dental implant suprastructure, permanent, preformed

DIRECT TITANIUM ATTACHMENTS - D821008MBG0

Used for measuring the gingival cuff height in order to choose the correct height of the abutment.
RHEIN 83 SRL
CUFF HEIGHT MEASURER
Not in Commercial Distribution

  • D821008MBG0 ()
008MBG

  • Dental implant suprastructure, permanent, preformed

Corning - H108118621

Corning CellSTACK Filling Accessory, 3 in tubing with Female MPC, Sterile, 1 per bag, 2 per case
Corning Incorporated
11862
In Commercial Distribution

  • H108118623 ()
  • H108118621 ()
11862

  • Blood/tissue storage/culture container

Proformix - M070PR05101

Multi-purpose implantable surgical mesh, collagen, bioabsorbable-for use in procedures such as achilles repair, rotator cuff and ligaments.
STELLEN MEDICAL, LLC
PR-0510
In Commercial Distribution

  • M070PR05101 ()

  • 5cm x 10cm
PR-0510

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

Proformix - M070PR04071

Multi-purpose implantable surgical mesh, collagen, bioabsorbable-for use in procedures such as achilles repair, rotator cuff and ligaments.
STELLEN MEDICAL, LLC
PR-0407
In Commercial Distribution

  • M070PR04071 ()

  • 4cm x 7cm
PR-04074

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

GrebSet® micro-introducer kit - M20679520

The GrebSet micro-introducer kit is indicated for use in percutaneous introduction and placement of catheters and guidewires.
Vascular Solutions, Inc.
7952
Not in Commercial Distribution

  • M20679520 ()
  • M20679521 ()

  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

GrebSet® micro-introducer kit - M20679510

The GrebSet micro-introducer kit is indicated for use in percutaneous introduction and placement of catheters and guidewires.
Vascular Solutions, Inc.
7951
Not in Commercial Distribution

  • M20679511 ()
  • M20679510 ()

  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

GrebSet® micro-introducer kit - M20679500

The GrebSet micro-introducer kit is indicated for use in percutaneous introduction and placement of catheters and guidewires.
Vascular Solutions, Inc.
7950
Not in Commercial Distribution

  • M20679501 ()
  • M20679500 ()

  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

ClearCorrect System - D865REF03001

The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner
Clearcorrect Operating, LLC
Aligner (Multi-layer)
In Commercial Distribution

REF03

  • Orthodontic progressive aligner
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