| Primary Device ID | 07899943604047 |
| NIH Device Record Key | f24bcdb4-afaa-4a60-ab73-6aae7d6a691d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIONNOVATION |
| Version Model Number | 05097 |
| Catalog Number | 05097 |
| Company DUNS | 903266968 |
| Company Name | BIONNOVATION PRODUTOS BIOMEDICOS LTDA. |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07899943604047 [Primary] |
| DZN | Instruments, Dental Hand |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
[07899943604047]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-03 |
| Device Publish Date | 2023-03-24 |
| 07899943601244 | DRIVE LOCK IMPLANT BIOMORSE LONG |
| 07899943601237 | DRIVE LOCK IMPLANT BIOMORSE SHORT |
| 07899943601114 | PARALLEL PINWP 3,1/4,1 MM |
| 07899943601107 | PARALLEL PINRP 2,1/3,1 MM |
| 07899943601091 | PARALLEL PINSP 2,1/2,7 MM |
| 07899943600872 | DRIVER FOR RATCHET ESFERICO/ORING |
| 07899943600834 | SQUARED RATCHED DRIVER SHORT |
| 07899943600810 | DRIVE LOCK FOR RATCHET HEX 0,9 MM SHORT |
| 07899943600797 | DRIVE LOCK FOR RATCHET HEX 1,2 MM SHORT |
| 07899943600766 | KEY CONTRA ANGLE BIODIRECT LONG |
| 07899943600759 | KEY CONTRA ANGLE BIODIRECT RP SHORT |
| 07899943600742 | DRIVE LOCK FOR RATCHET BIODIRECT LONG |
| 07899943600735 | DRIVE LOCK FOR RATCHET BIODIRECT SHORT |
| 07899943600728 | SURGICAL TORQUE WRENCH MANUAL |
| 07899943600582 | KEY CONTRA ANGLE SQUARE24MM |
| 07899943600513 | SURGICAL KIT |
| 07899943600490 | DEPTH GAUGE 2,20 MM |
| 07899943600476 | IMPLANT DEPTH GAUGE |
| 07899943600421 | DRILL EXTENDER |
| 07898628611080 | SCREW GRAFT KIT37 X 75 X 160 MM |
| 07898628611073 | SCREW DRIVER HANDLE |
| 07898628611066 | ROD INSTALLATION SCREW GRAFT 70MM |
| 07898628611059 | KEY CONTRA ANGLE SCREW GRAFT LONG |
| 07898628611042 | KEY CONTRA ANGLE SCREW GRAFT SHORT |
| 07898628611035 | TWIST DRILL1,6 X 15 MM |
| 07898628611028 | TWIST DRILL1,4 X 15 MM |
| 07898628611011 | TWIST DRILL1,2 X 15 MM |
| 07898628611004 | TWIST DRILL1,0 X 15 MM |
| 07898628610991 | TORQUE WRENCH FOR SCREW GRAFT LONG |
| 07898628610984 | TORQUE WRENCH FOR SCREW GRAFT SHORT |
| 07898628610977 | ADAPTER DRIVER HANDLE |
| 07899943604108 | TWIST DRILL2,2 X 15 MM DLC |
| 07899943604092 | CONICAL DRILL2,8 X 15 MM DLC |
| 07899943604085 | CONICAL DRILL 3,2 X 15 MM DLC |
| 07899943604078 | CONICAL DRILL 4,2 X 15 MM DLC |
| 07899943604047 | CONICAL DRILL 4,4 X 15 MM DLC |
| 07899943604030 | CONICAL DRILL 4,0 X 15 MM DLC |
| 07899943604023 | GUIDE DRILL LANCE DRILLDLC |
| 07899943601299 | HEIGHT GAUGE FOR ABUTMENT BIOMORSE |
| 07899943601268 | KEY CONTRA ANGLE BIOMORSE LONG |
| 07899943601251 | KEY CONTRA ANGLE BIOMORSE SHORT |