Exact Osteotomy System

GUDID B562OGSYWG10

EXACT OSTEOTOMY SYSTEM - YOUNGWICK GUIDE (1MM)

WISHBONE MEDICAL, INC.

Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use Osteotomy guide, single-use
Primary Device IDB562OGSYWG10
NIH Device Record Key1e7bcc66-0fd6-4d94-b39e-b24886f684b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameExact Osteotomy System
Version Model NumberOGS-YWG1
Company DUNS062355158
Company NameWISHBONE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB562OGSYWG10 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-24
Device Publish Date2021-09-16

On-Brand Devices [Exact Osteotomy System]

B562OGSYWG30EXACT OSTEOTOMY SYSTEM - YOUNGWICK GUIDE (3MM)
B562OGSYWG20EXACT OSTEOTOMY SYSTEM - YOUNGWICK GUIDE (2MM)
B562OGSYWG10EXACT OSTEOTOMY SYSTEM - YOUNGWICK GUIDE (1MM)
B562OGSSCZG0EXACT OSTEOTOMY SYSTEM - SCARF Z GUIDE
B562OGSPDG20EXACT OSTEOTOMY SYSTEM - PASA/DMAA (2-STAGE GUIDE)
B562OGSLA450EXACT OSTEOTOMY SYSTEM - LONG ARM GUIDE (45-DEGREE)
B562OGSDMAA0EXACT OSTEOTOMY SYSTEM - DMAA GUIDE
B562OGSCA550EXACT OSTEOTOMY SYSTEM - CHEVRON/AUSTIN (55 DEGREE)

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