OTIS-F EVO9000000

GUDID 03760154009492

Complete instrumentation tray composed of reusable surgical instruments intended to be used for high tibial osteotomy with the OTIS-F plate.

S.B.M

General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable

Primary Device ID	03760154009492
NIH Device Record Key	c122d7ee-e9f6-4560-a2b2-67e6201b32b0
Commercial Distribution Status	In Commercial Distribution
Brand Name	OTIS-F
Version Model Number	Complete OTIS-F tray
Catalog Number	EVO9000000
Company DUNS	772462123
Company Name	S.B.M
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154009492 [Primary]

FDA Product Code

LXH	Orthopedic Manual Surgical Instrument