Elite® Band Assemblies

GUDID 00190707096939

.022 Elite® LR6 Std Buccal Tube Epic / Sheath (E)

Ortho Organizers, Inc.

Orthodontic metal band

• Primary Device ID: 00190707096939
• NIH Device Record Key: 5f8a3f9c-49e2-489c-9813-94ccf80e7f02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite® Band Assemblies
• Version Model Number: 900-121066E
• Company DUNS: 062165188
• Company Name: Ortho Organizers, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• 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	00190707096939 [Primary]

FDA Product Code

• ECM: BAND, PREFORMED, 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: 2
• Public Version Date: 2025-12-19
• Device Publish Date: 2022-01-06

On-Brand Devices [Elite® Band Assemblies]

• 00190707081393: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 44
• 00190707081386: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 43.5
• 00190707081379: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 43
• 00190707081362: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 42.5
• 00190707081355: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 42
• 00190707081348: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 41.5
• 00190707081331: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 41
• 00190707081324: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 40.5
• 00190707081317: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 40
• 00190707081300: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 39.5
• 00190707081294: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 39
• 00190707081287: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 38.5
• 00190707081270: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 38
• 00190707081263: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 37.5
• 00190707081256: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 37
• 00190707081249: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 36.5
• 00190707081232: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 36
• 00190707081225: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 35.5
• 00190707081218: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 35
• 00190707081201: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 34.5
• 00190707081195: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 34
• 00190707081188: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 33.5
• 00190707081171: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 33
• 00190707081164: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 32.5
• 00190707081157: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 32
• 00190707081140: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 31.5
• 00190707081133: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 31
• 00190707081126: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 30.5
• 00190707081119: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 30
• 00190707081102: 022/045 Elite® UR6 OCBT -10T/0A+10Off Tempra - Cleat 29.5
• 00190707081096: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 44
• 00190707081089: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 43.5
• 00190707081072: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 43
• 00190707081065: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 42.5
• 00190707081058: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 42
• 00190707081041: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 41.5
• 00190707081034: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 41
• 00190707081027: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 40.5
• 00190707081010: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 40
• 00190707081003: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 39.5
• 00190707080990: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 39
• 00190707080983: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 38.5
• 00190707080976: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 38
• 00190707080969: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 37.5
• 00190707080952: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 37
• 00190707080945: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 36.5
• 00190707080938: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 36
• 00190707080921: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 35.5
• 00190707080914: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 35.5
• 00190707080907: 022/045 Elite® UL6 OCBT -10T/0A+10Off Tempra - Cleat 34.5