Black Belt Blunt Ti Blade 7320-C-22-80

GUDID 00840199545254

Black Belt Blunt Titanium Blade 22 x 80mm

KOROS U.S.A., INC.

Surgical retractor/retraction system blade, reusable

Primary Device ID	00840199545254
NIH Device Record Key	8e2d73b5-e786-4fb2-a983-d06ea45fc02b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Black Belt Blunt Ti Blade
Version Model Number	7320-C-22-80
Catalog Number	7320-C-22-80
Company DUNS	007928633
Company Name	KOROS U.S.A., 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	true
Manufacturing Date	false
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

Customer Support Contacts

Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com
Phone	1-805-529-0825
Email	customerservice@korosUSA.com

Device Dimensions

Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter
Width	22 Millimeter
Depth	100 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in dry place at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840199545254 [Direct Marking]
GS1	10840199545251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K935529

FDA Product Code

GZT	Retractor, Self-Retaining, For Neurosurgery