Ormco

GUDID 00889989063080

LIGATURE DIRECTOR/SCALER

ORMCO CORPORATION

Orthodontic ligature director

• Primary Device ID: 00889989063080
• NIH Device Record Key: 80e8a7c3-6575-4744-8e76-cc6f21a11c2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ormco
• Version Model Number: 803-0159
• Company DUNS: 154614119
• Company Name: ORMCO CORPORATION
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889989063080 [Primary]

FDA Product Code

• ECP: INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC

Sterilization

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

[00889989063080]

Moist Heat or Steam Sterilization

[00889989063080]

Moist Heat or Steam Sterilization

[00889989063080]

Moist Heat or Steam Sterilization

[00889989063080]

Moist Heat or Steam Sterilization

[00889989063080]

Moist Heat or Steam Sterilization

[00889989063080]

Moist Heat or Steam Sterilization

[00889989063080]

Moist Heat or Steam Sterilization

[00889989063080]

Moist Heat or Steam Sterilization

[00889989063080]

Moist Heat or Steam Sterilization

[00889989063080]

Moist Heat or Steam Sterilization

[00889989063080]

Moist Heat or Steam Sterilization

[00889989063080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

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