Primary Device ID | B562OGSYWG20 |
NIH Device Record Key | 7e6ab280-7df7-4848-bfcf-a0db5892074e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Exact Osteotomy System |
Version Model Number | OGS-YWG2 |
Company DUNS | 062355158 |
Company Name | WISHBONE MEDICAL, INC. |
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 | false |
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 |
---|---|
HIBCC | B562OGSYWG20 [Primary] |
FZX | Guide, Surgical, Instrument |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-24 |
Device Publish Date | 2021-09-16 |
B562OGSYWG30 | EXACT OSTEOTOMY SYSTEM - YOUNGWICK GUIDE (3MM) |
B562OGSYWG20 | EXACT OSTEOTOMY SYSTEM - YOUNGWICK GUIDE (2MM) |
B562OGSYWG10 | EXACT OSTEOTOMY SYSTEM - YOUNGWICK GUIDE (1MM) |
B562OGSSCZG0 | EXACT OSTEOTOMY SYSTEM - SCARF Z GUIDE |
B562OGSPDG20 | EXACT OSTEOTOMY SYSTEM - PASA/DMAA (2-STAGE GUIDE) |
B562OGSLA450 | EXACT OSTEOTOMY SYSTEM - LONG ARM GUIDE (45-DEGREE) |
B562OGSDMAA0 | EXACT OSTEOTOMY SYSTEM - DMAA GUIDE |
B562OGSCA550 | EXACT OSTEOTOMY SYSTEM - CHEVRON/AUSTIN (55 DEGREE) |