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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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F-Scan GO - B970FG2PRO0

Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 Pro In-Shoe Pressure Measurement Software, 2 Velcro Ankle Bands, 20 In-Shoe Sensors (model 3010-125), 4 Li-Po Battery Packs, 2 Battery Chargers, 2 USB-C to USB-A cables, Wireless Router, Quick Start Guide, System Carrying Case and 1 On-line Training Session (USA Only)
Tekscan, Inc.
F-Scan GO System with FootVIEW Pro
In Commercial Distribution

  • B970FG2PRO0 ()
FG2PRO

  • Body-surface pressure mapping system

PDT, Inc. - 00813677024992

Kit Includes: (T007B-F) B-Series FlipTop™ Cassette - Fixed Rack 7 (R006) 11-12 Amazing Gracey™ Extended Reach Mini (R007) 13-14 Amazing Gracey™ Extended Reach Mini (R064) Columbia 13-14 (R130S) Jack B. Nimble® (R138) Montana Jack® (R224) 23 Explorer-Williams O Probe (R245) Cone Socket Mirror Handle (T050) #5 Mirror (15/16")
PDT, INC.
R970 Just Be Nice Hygiene Kit with Cassette
In Commercial Distribution

  • 00813677024992 ()
R970

  • Dental mirror, reusable
  • Instrument tray, reusable
  • Periodontal curette
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle

PDT, Inc. - 00813677024831

Kit Includes: T009C-D C-Series FlipTop™ Cassette - Double Rack 18 R061 Barnhart 5-6 R080 Langer 3-4 R130S Jack B. Nimble® Slim R138 Montana Jack® R144 Queen of Hearts™ R167 11-12 ODU Explorer R223 23 Explorer-12 Probe R245 Cone Socket Mirror Handle T043 Cotton Pliers T050 #5 Mirror (15/16”)
PDT, INC.
R913 PDT I Dream of Hygiene™ Kit
In Commercial Distribution

  • 00813677024831 ()
R913

  • Manual dental scaler, reusable
  • Periodontal curette
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Manual non-rotary dental instrument handle
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental mirror, reusable

PDT, Inc. - 00813677024862

Kit Includes: T009C-F C-Series FlipTop™ Cassette - Fixed Rack 9 R026 Amazing Gracey™ 11-12 R028 Amazing Gracey™ 13-14 R061 Barnhart 5-6 R130 Jack B. Nimble® R138 Montana Jack® R144 Queen of Hearts™ R167 11-12 ODU Explorer R195 Probe 12 (3-6-9-12) R245 Cone Socket Mirror Handle T050 #5 Mirror (15/16")
PDT, INC.
R917 PDT Amazing Gracey™ Prophy Kit
In Commercial Distribution

  • 00813677024862 ()
R917

  • Dental mirror, reusable
  • Manual dental scaler, reusable
  • Periodontal curette
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Manual non-rotary dental instrument handle

DataLINK DLK900 - 05060481691925

DataLINK (DLK900) is an on-line general purpose subject worn programmable Data Acquisition System allowing the user to collect both analog and digital data from a wide range of wired sensors including Biometrics' Goniometers, Torsiometers, active EMG sensors, Accelerometers, Pinchmeters, Hand Dynamometers and Contact Switches. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
DLK900
In Commercial Distribution

  • 05060481691925 ()
DataLINK DLK900 - plastic connectors

  • Biomechanical function analysis system, motion-tracking

DataLINK DLK900 - 05060481692052

DataLINK (DLK900) is an on-line general purpose subject worn programmable Data Acquisition System allowing the user to collect both analog and digital data from a wide range of wired sensors including Biometrics' Goniometers, Torsiometers, active EMG sensors, Accelerometers, Pinchmeters, Hand Dynamometers and Contact Switches. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13.
BIOMETRICS LIMITED
DLK900
In Commercial Distribution

  • 05060481692052 ()
DataLINK DLK900 - metal connectors

  • Biomechanical function analysis system, motion-tracking

PDT, Inc. - 00813677025142

Kit Includes: R026 Amazing Gracey™ 11-12 R028 Amazing Gracey™ 13-14 R061 Barnhart 5-6 R093 N128-L5 Mini R096 N1 R130S Jack B. Nimble® Slim Scaler R135 204S R138 Montana Jack® R166 Explorer 5 R167 Explorer ODU 11-12 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) T009D-F15 FlipTop™ Cassette 'D' - Fixed Rack 15 T055 Double-Sided PrecisionReflect HD
PDT, INC.
R985 Rev B Andy RDH Student Kits
In Commercial Distribution

  • 00813677025142 ()
R983 Rev C

  • Periodontal curette
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Instrument tray, reusable
  • Dental mirror, reusable

PDT, Inc. - 00813677029324

Kit Containing: R138T - Montana Jack Titanium R696 - Amazing Gracey 13-14 Titanium Extended Reach Micro Mini R630 - Pineyro Arch Ti1 R631 - Pineyro Arch Ti2 R632 - Pineyro Arch Ti3 R633 - Pineyro Arch Ti4 R661 - Wingrove B 5-6 Titanium Implant R680 - Wingrove L 3-4 Titanium Implant R693 - Wingrove N128 Blunt-Langer 5 Mini Titanium Implant T216 - EasyView UNC12 Probe T061 - Diamond Head Ceramic Stone E-Z Jett Cassette 10-Place
PDT, INC.
R932 Ultimate Implant Kit
In Commercial Distribution

  • 00813677029324 ()
R932

  • Manual dental scaler, reusable
  • Periodontal curette
  • Dental surgical probe, reusable
  • Instrument tray, reusable

PDT, Inc. - 00813677024961

Kit Includes: (T009D-F) D-Series FlipTop™ Cassette - Fixed Rack 9 (R138) Montana Jack® (R166) 5 Explorer (R195) 12 Probe (R245) Cone Socket Mirror Handle (R286) G2 Thin Composite (R362) 113 Off Angle Cord Packer (R375) Mixing Spatula-Applicator (R386) 38-39 Excavator (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T800) Iris Curved Scissors (11.5cm)
PDT, INC.
R935 PDT Crown & Bridge Kit
In Commercial Distribution

  • 00813677024961 ()
R935

  • Dental restoration carver, amalgam, reusable
  • Dental mirror, reusable
  • Instrument tray, reusable
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Gingival retraction cord packing tool
  • Dental spatula, reusable
  • Dental excavator, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental irrigation/aspiration syringe
  • Suture scissors

PDT, Inc. - 00813677024626

Kit includes: R026 Amazing Gracey™ 11-12 R028 Amazing Gracey™ 13-14 R061 Barnhart 5-6 R093 N128-L5 Mini R096 N1 R130S Jack B. Nimble® Slim Scaler R135 204S R138 Montana Jack® R166 Explorer 5 R167 Explorer ODU 11-12 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) T009C-D FlipTop™ Cassette 'C' - Double Rack 18 T050 #5 Front Surface Mirror, Cone-Socket, (15/16')
PDT, INC.
R985 Andy RDH Student Kit
In Commercial Distribution

  • 00813677024626 ()
R985

  • Periodontal curette
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Instrument tray, reusable
  • Dental mirror, reusable
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