Breiten Sterilization Tray 10964

GUDID 00816728020301

The Breiten Sterilization Tray is intended to allow sterilization of the enclosed medical devices.

INVUITY, INC.

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

Primary Device ID	00816728020301
NIH Device Record Key	eccfc60b-3c8c-45b1-80a7-083c660b4ffb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Breiten Sterilization Tray
Version Model Number	Narrow
Catalog Number	10964
Company DUNS	175697908
Company Name	INVUITY, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com
Phone	8667117768
Email	customerservice@invuity.com

Device Dimensions

Width	15 Millimeter
Width	15 Millimeter
Width	15 Millimeter
Width	15 Millimeter
Width	15 Millimeter
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter
Device Size Text, specify	0
Width	15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816728020301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K090070

FDA Product Code

FST	Light, Surgical, Fiberoptic