ClassOne

GUDID 00190707005573

RELEASE MODULES-HEAVY FORCE-BLACK

ORTHO ORGANIZERS, INC.

Orthodontic extraoral headgear

• Primary Device ID: 00190707005573
• NIH Device Record Key: 23bb5adb-6f47-428f-835b-1b6b988914c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClassOne
• Version Model Number: 874-0516
• 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	00190707005573 [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: 2019-03-15
• Device Publish Date: 2016-09-24

On-Brand Devices [ClassOne]

• 00190707045012: Rainbow Elastics Heavy 3/8 (6.5oz)
• 00190707045005: Rainbow Elastics Heavy 5/16 (6.5oz)
• 00190707044992: Rainbow Elastics Heavy 1/4 (6.5oz)
• 00190707044985: Rainbow Elastics Heavy 3/16 (6.5oz)
• 00190707044978: Rainbow Elastics Heavy 1/8 (6.5oz)
• 00190707044961: Rainbow Elastics Medium 3/8 (4.5oz)
• 00190707044954: Rainbow Elastics Medium 5/16 (4.5oz)
• 00190707044947: Rainbow Elastics Medium 1/4 (4.5oz)
• 00190707044930: Rainbow Elastics Medium 3/16 (4.5oz)
• 00190707044923: Rainbow Elastics Medium 1/8 (4.5oz)
• 00190707044916: Natural Elastics Heavy 3/8 (6.5oz)
• 00190707044909: Natural Elastics Heavy 5/16 (6.5oz)
• 00190707044893: Natural Elastics Heavy 1/4 (6.5oz)
• 00190707044886: Natural Elastics Heavy 3/16 (6.5oz)
• 00190707044879: Natural Elastics Heavy 1/8 (6.5oz)
• 00190707044862: Natural Elastics Medium 3/8 (4.5oz)
• 00190707044855: Natural Elastics Medium 5/16 (4.5oz)
• 00190707044848: Natural Elastics Medium 1/4 (4.5oz)
• 00190707044831: Natural Elastics Medium 3/16 (4.5oz)
• 00190707044824: Natural Elastics Medium 1/8 (4.5oz)
• 00190707044817: Natural Elastics Light 3/8 (2.5oz)
• 00190707044800: Natural Elastics Light 5/16 (2.5oz)
• 00190707044794: Natural Elastics Light 1/4 (2.5oz)
• 00190707044787: Natural Elastics Light 3/16 (2.5oz)
• 00190707043384: SEPARATORS POSTERIOR - LIGHT BLUE
• 00190707042622: DB Lingual Button - Rectangular Curved Nickel-Free
• 00190707042615: DB Lingual Button - Round Curved Nickel-Free
• 00190707007713: PEDO CHEEK RETRACTORS
• 00190707007706: ADULT CHEEK RETRACTORS
• 00190707007690: TEEN CHEEK RETRACTORS
• 00190707005573: RELEASE MODULES-HEAVY FORCE-BLACK
• 00190707005566: RELEASE MODULES- MEDIUM-FORCE-BLACK
• 00190707005542: RELEASE MODULES- MEDIUM FORCE
• 00190707005528: HIGHPULL HEAD CAPS HAPPY MULTI-MEDIUM
• 00190707005511: HIGHPULL HEAD CAPS-ROYAL BLUE-MEDIUM
• 00190707005504: HIGH PULL HEAD CAPS-BLACK-MEDIUM
• 00190707005498: NECK PADS- CAMOUFLAGE
• 00190707005481: NECK PADS- PURPLE
• 00190707005474: NECK PADS-FUN MULTI COLOR
• 00190707005467: NECK PADS- SPORTS ASSORTED
• 00190707005450: NECK PADS- ROYAL BLUE
• 00190707005443: NECK PADS- DENIM
• 00190707005436: NECK PADS- NAVY
• 00190707005429: NECK PADS- PINK
• 00190707005412: NECK PADS- KHAKI
• 00190707005405: NECK PADS- PEACOCK BLUE
• 00190707005399: ALGINATE FLAVOR-WATERMELON
• 00190707005382: ALGINATE FLAVORING-VANILLA
• 00190707005375: ALGINATE FLAVORING- APPLE
• 00190707005368: ALGINATE FLAVOR-COTTON CANDY