Masel

GUDID 00190707000356

SAFETY RELEASE MODULE MEDIUM FORCE

ORTHO ORGANIZERS, INC.

Orthodontic extraoral headgear

• Primary Device ID: 00190707000356
• NIH Device Record Key: 392d20bc-950b-4802-8ef0-4f5a98d5143b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Masel
• Version Model Number: 1126-002
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190707000356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961754

FDA Product Code

• DZB: Headgear, extraoral, orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-14
• Device Publish Date: 2016-09-24

On-Brand Devices [Masel]

• 00190707054717: REPLACEMENT PADS & KEY KIT
• 00190707053598: TRIPLE TWIST R STAINLESS STEEL WIRE .0175 30FT SPOOL
• 00190707053581: TRIPLE TWIST R STAINLESS STEEL WIRE .0155 30FT SPOOL
• 00190707053499: ELASTINOL™ NITI FORCE OPEN COIL SPRINGS 50 GR 15"
• 00190707053482: ELASTINOL™ NITI FORCE OPEN COIL SPRINGS 100 GR 15"
• 00190707053475: ELASTINOL™ NITI FORCE OPEN COIL SPRINGS 150 GR 15"
• 00190707053468: ELASTINOL™ NITI VARIABLE OPEN COIL SPRINGS .014 X .036 15"
• 00190707053451: ELASTINOL™ NITI VARIABLE OPEN COIL SPRINGS .014 X .030 15"
• 00190707053444: ELASTINOL™ NITI VARIABLE OPEN COIL SPRINGS .012 X .030 15"
• 00190707053437: ELASTINOL™ NITI VARIABLE OPEN COIL SPRINGS .010 X .036 15"
• 00190707053420: ELASTINOL™ NITI VARIABLE OPEN COIL SPRINGS .010 X .030 15"
• 00190707053413: ELASTINOL™ NITI VARIABLE OPEN COIL SPRINGS .009 X .030 15"
• 00190707053406: ELASTINOL™ VARIABLE FORCE OPEN COIL SPRINGS 15MM
• 00190707053390: ELASTINOL™ CLOSED COIL SPRINGS 200GR 9MM
• 00190707053383: ELASTINOL™ CLOSED COIL SPRINGS 150GR 9MM
• 00190707053376: ELASTINOL™ CLOSED COIL SPRINGS 100GR 9MM
• 00190707053369: ELASTINOL™ VARIABLE CLOSED COIL SPRINGS 12MM
• 00190707053352: ELASTINOL™ VARIABLE CLOSED COIL SPRINGS 9MM
• 00190707053345: .021 X.025 ARCHWIRE SPLIT RECTANGULAR STOPS
• 00190707053338: .018 X.025 ARCHWIRE SPLIT RECTANGULAR STOPS
• 00190707053321: .010 X .030 VARIABLE FORCE SPRING 12MM
• 00190707053314: .010 X .030 VARIABLE FORCE SPRING 9MM
• 00190707053307: .010 X .030 VARIABLE FORCE SPRING 6MM
• 00190707053031: NICKEL TITANIUM DISTALIZING COIL SPRING 7" OPEN
• 00190707053024: .014 KOBAYASHI PREFORMED LIGATURE TIES
• 00190707053017: .012 KOBAYASHI PREFORMED LIGATURE TIES
• 00190707053000: .010 KOBAYASHI PREFORMED LIGATURE TIES
• 00190707052973: .0215 STAINLESS STEEL PENTA-ONE WIRE 14" STRAIGHT LENGTHS
• 00190707052966: .0195 STAINLESS STEEL PENTA-ONE WIRE 14" STRAIGHT LENGTHS
• 00190707052959: .0175 STAINLESS STEEL PENTA-ONE WIRE 14" STRAIGHT LENGTHS
• 00190707052942: .0155 STAINLESS STEEL PENTA-ONE WIRE 14" STRAIGHT LENGTHS
• 00190707052935: .0215 STAINLESS STEEL TRIPLE TWIST R WIRE 14" STRAIGHT LENGTHS
• 00190707052928: .0195 STAINLESS STEEL TRIPLE TWIST R WIRE 14" STRAIGHT LENGTHS
• 00190707052911: .0175 STAINLESS STEEL TRIPLE TWIST R WIRE 14" STRAIGHT LENGTHS
• 00190707052904: .0155 STAINLESS STEEL TRIPLE TWIST R WIRE 14" STRAIGHT LENGTHS
• 00190707052898: .021X.025 STAINLESS STEEL SPRING TEMPER WIRE 14" LENGTHS
• 00190707052881: DIRECT BOND BUTTON ROUND FLAT BASE
• 00190707052874: FLATBOW LABIAL ARCHWIRES 1 7/8"
• 00190707052867: FLATBOW LABIAL ARCHWIRES 1 3/4"
• 00190707052850: FLATBOW LABIAL ARCHWIRES 1 5/8"
• 00190707052843: FLATBOW LABIAL ARCHWIRES 1 1/2"
• 00190707052836: FLATBOW LABIAL ARCHWIRES 1 3/8"
• 00190707052829: FLATBOW LABIAL ARCHWIRES 1 1/4"
• 00190707052812: FLATBOW LABIAL ARCHWIRES 1 1/8"
• 00190707052805: FLATBOW LABIAL ARCHWIRES 1"
• 00190707052799: STAINLESS STEEL WIRE TEMPER SPRINGS .019X.025 14" LENGTHS
• 00190707052782: STAINLESS STEEL WIRE TEMPER SPRINGS .018X.025 14" LENGTHS
• 00190707052775: STAINLESS STEEL WIRE TEMPER SPRINGS .017X.025 14" LENGTHS
• 00190707052768: STAINLESS STEEL WIRE TEMPER SPRINGS .017X.022 14" LENGTHS
• 00190707052751: STAINLESS STEEL WIRE TEMPER SPRINGS .016X.022 14" LENGTHS