Ormesh

GUDID 10889989015703

ORMESH NTWIN LANT 1120007 -1T 0A 022

ORMCO CORPORATION

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal

• Primary Device ID: 10889989015703
• NIH Device Record Key: 8ea0f89f-327f-4e4c-b759-4af6029f7377
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ormesh
• Version Model Number: 342-1500
• 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
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• 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	00889989015706 [Primary]
GS1	10889989015703 [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: 2024-03-15
• Device Publish Date: 2024-03-07

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