Ormco

GUDID 00889989014136

EDGW BRKT MED TW 018

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: 00889989014136
• NIH Device Record Key: 32500aa6-120c-4f15-9b46-4cf76d894323
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ormco
• Version Model Number: 100-3018
• Company DUNS: 154614119
• Company Name: ORMCO CORPORATION
• Device Count: 1
• 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	00889989014136 [Primary]

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 [Ormco]

• 00889989075762: HANDLE CAP REMOVER
• 00889989075748: MOSQUITO HEMOSTAT
• 10889989074649: COATED LIGATURE WIRE PACK/100 2-1214
• 00889989068214: COTTON TWEEZER
• 00889989063097: ORTHODONTIC BAND PUSHER/SCALER 2
• 00889989063080: LIGATURE DIRECTOR/SCALER
• 00889989063073: DOUBLE END LIGATURE DIRECTOR
• 00889989062960: POSITIONER ELASTIC FOR POWER -0- PKD
• 00889989062953: ETM8015-W SMAHA SLIMLINE WIDE
• 00889989062830: ETM8014 SMAHA SLIMLINE SURE-GRIP CVD
• 00889989062823: ETM8013 MOSQUITO FORCEP STRAIGHT
• 00889989062762: ETM2108 ASPEL FORCE MODULE INSTRUMENT
• 00889989062755: ETM2106 #5 MOUTH MIRROR
• 00889989062748: ETM2104 LIGATURE DIRECTOR
• 10889989059424: PLETCHER SPRINGS 11X30 PK50
• 10889989059417: PLETCHER SPRINGS 09X30 PK50
• 20889989056123: ELASTIC SEPARATOR POSTERIOR PK/1000
• 10889989033912: KOBAYASHI AUX TIE HOOK 016DIA PK/100
• 10889989033905: KOBAYASHI AUX TIE HOOK 014DIA PK/100
• 10889989033899: KOBAYASHI AUX TIE HOOK 012DIA PK/100
• 10889989033882: MINI-TWIST KOBY HOOK-COATED16PK/100
• 10889989033875: MINI-TWIST KOBAYASHI HOOK 14 PK/100
• 10889989033868: MINI-TWIST KOBAYASHI HOOK 12 PK/100
• 20889989033858: WIRE LIGATURE P/F 12DIA PK 1000
• 20889989033841: WIRE LIGATURE P/F 11DIA PK 1000
• 20889989033834: WIRE LIGATURE P/F 10DIA PK 1000
• 20889989033827: WIRE LIGATURE P/F 09DIA PK 1000
• 20889989033162: BURSTONE LWR LINGUAL ARCH 032 DIA TMA PK 10
• 20889989033155: BURSTONE LING ARCH LWR 32X32 TMA PK10
• 20889989033148: BURSTONE TRANSPALATAL ARCH 032DIA TMA PK 10
• 20889989033131: BURSTONE TRANPAL ARCH 32X32 TMA PK/10
• 20889989033124: BURSTONE LWR LINGUAL ARCH 32X32 SST PK 10
• 20889989033117: BURSTONE TRANSPALATAL ARCH 32X32 SST PK 10
• 10889989031345: QUICK NANCE - SIZE 3 - PK OF 10
• 10889989031338: QUICK NANCE - SIZE 2 - PK OF 10
• 10889989031321: QUICK NANCE - SIZE 1 - PK OF 10
• 00889989031317: SPRING COIL CLOSE WOUND PKG 010 X 030
• 10889989031307: STOP WOUND SPRING TMA 100X60 PK3
• 00889989031294: SPRING COIL CLOSE WOUND PKG 009 X 030
• 10889989031284: STOP WOUND SPRING TMA 090X60 PK3
• 00889989031270: SPRING COIL CLOSE WOUND PKG 008 X 030
• 10889989031260: COMPRESSION SPRING NITI 014X036 PK 3
• 10889989031253: COMPRESSION SPRING NITI 012X030 PK3
• 10889989031246: COMPRESSION SPRING NITI 010X030 PK 3
• 10889989031239: COMPRESSION SPRING TMA 115X60 PK3
• 00889989031225: SPRING COIL SPACE WOUND PKG 010 X 030
• 10889989031215: COMPRESSION SPRING TMA 100X60 PK3
• 00889989031201: SPRING COIL SPACE WOUND PKG 009 X 030
• 10889989031192: COMPRESSION SPRING TMA 090X60 PK3
• 00889989031188: SPRING COIL SPACE WOUND PKG 008 X 030