Ormesh

GUDID 20889989015380

ORMESH TWEED U BIC 1700237 0T 0A 022

ORMCO CORPORATION

Orthodontic bracket, metal

• Primary Device ID: 20889989015380
• NIH Device Record Key: ca7e3dea-bda2-44f0-87b2-175bd7ee65af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ormesh
• Version Model Number: 342-0414
• Company DUNS: 154614119
• Company Name: ORMCO CORPORATION
• Device Count: 10
• DM Exempt: false
• 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

Customer Support Contacts

• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889989015386 [Primary]
GS1	20889989015380 [Unit of Use]

FDA Product Code

• EJF: BRACKET, METAL, ORTHODONTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Ormesh]

• 10889989047728: ORMESH MINI-D MTWN ULCUS W/HK 0T10A 018
• 10889989047711: ORMESH MINI-D MTWN URCUS W/HK 0T10A 018
• 10889989017349: ORMESH PIX TUBE 22 X 028 X 2MM LONG
• 10889989017332: ORMESH PIX TUBE 18 X 025 X 2MM LONG
• 10889989017325: ORMESH FLAT LING PAD W/BUTTON
• 10889989017318: ORMESH CURVE LING PAD W/BUTTON
• 10889989017295: ORMESH CURVE LING PAD W/CLT
• 10889989015741: ORMESH MTW L1BI 1700211 -11T 0A 022
• 10889989015734: ORMESH MTW L2BI 1700213 -17T 0A 022
• 10889989015727: ORMESH MTWIN L2BI 1700215 -22T 0A 022
• 10889989015697: ORMESH MTWIN UBIC 1700207 -7T 0A 022
• 10889989015598: ORMESH LFM B/T 5DEG -22T 022 W/HK LT
• 10889989015543: ORMESH LFM B/T 5DEG -22T 022 W/HK RT
• 10889989015536: ORMESH MTW ULBI 1700207 -7T 0A WHK022
• 10889989015529: ORMESH UFM B/T 5DEG -10T 022 W/HK LT
• 10889989015512: ORMESH MTW URBI 1700207 -7T 0A WHK022
• 10889989015505: ORMESH UFM B/T 5DEG -10T 022 W/HK RT
• 10889989015499: PEERLESS ORMESH 2ND B/T 12DEG -10T 022 UL
• 10889989015482: PEERLESS ORMESH 2ND B/T 12DEG -27T 022 LL
• 20889989015458: ORMESH TWEED L BIC 1700237 0T 0A 022
• 20889989015441: ORMESH TWEED L CUSP 1000209 0T 0A 022
• 20889989015434: ORMESH TWEED L ANT 1700237 0T 0A 022
• 10889989015420: PRLS ORMESH 2ND B/T 12DEG -10T 022 UR
• 10889989015413: PRLS ORMESH 2ND B/T 12DEG -27T 022 LR
• 20889989015380: ORMESH TWEED U BIC 1700237 0T 0A 022
• 20889989015373: ORMESH TWEED UCUSP 1000209 0T 0A 022
• 20889989015366: ORMESH TWEED U LAT 1000209 0T 0A 022
• 20889989015359: ORMESH TWEED UCENT 1000209 0T 0A 022
• 10889989014416: PRLS ORMESH 2ND B/T 12DEG -10T 018 UL
• 10889989014409: PRLS ORMESH 2ND B/T 12DEG -27T 018 LL
• 10889989014379: PRLS ORMESH 2ND B/T 12DEG -10T 018 UR
• 10889989014362: PRLS ORMESH 2ND B/T 12DEG -27T 018 LR
• 00889989086409: ORMESH PAD MOLAR U/L
• 00889989086386: ORMESH SLIM II MOLARPAD UPR/LWR
• 00889989017304: ORMESH CURVE LING PAD W/ELASTLUG
• 10889989015710: ORMESH MTWIN L1BI 1700213 -17T 0A 022
• 10889989015703: ORMESH NTWIN LANT 1120007 -1T 0A 022
• 00889989015607: ORMESH MTW LLIBI 1700211 -11T 0AWHK22
• 00889989015553: ORMESH MTW LR1BI 1700211 -11T 0AWHK22
• 00889989014587: ORMESH MTWIN L1BI 1700212 -11T 0A 018
• 00889989014563: ORMESH MTWIN L2BI 1700216 -22T 0A 018
• 00889989014556: ORMESH MTWIN L 1BI 1700214 -17T 0A 18