| Primary Device ID | 00889989075762 |
| NIH Device Record Key | 6527e71b-d350-4b88-85ce-b14575a9ea92 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ormco |
| Version Model Number | 801-0095 |
| 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 | 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 |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889989075762 [Primary] |
| JEX | PLIER, ORTHODONTIC |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889989075762]
Moist Heat or Steam Sterilization
[00889989075762]
Moist Heat or Steam Sterilization
[00889989075762]
Moist Heat or Steam Sterilization
[00889989075762]
Moist Heat or Steam Sterilization
[00889989075762]
Moist Heat or Steam Sterilization
[00889989075762]
Moist Heat or Steam Sterilization
[00889989075762]
Moist Heat or Steam Sterilization
[00889989075762]
Moist Heat or Steam Sterilization
[00889989075762]
Moist Heat or Steam Sterilization
[00889989075762]
Moist Heat or Steam Sterilization
[00889989075762]
Moist Heat or Steam Sterilization
[00889989075762]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-14 |
| Device Publish Date | 2022-12-06 |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORMCO 72197753 0805280 Live/Registered |
ORMCO CORPORATION 1964-07-13 |