Extended Excel Black Belt PRO Retractor Set 7320-05PE

GUDID 00840199545803

Extended Excel Black Belt PRO Retractor Set

KOROS U.S.A., INC.

Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable

Primary Device ID	00840199545803
NIH Device Record Key	5488fa64-0633-4d78-a3e1-622a4458b96c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Extended Excel Black Belt PRO Retractor Set
Version Model Number	7320-05PE
Catalog Number	7320-05PE
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	true
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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840199545803 [Direct Marking]
GS1	10840199545800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K935529

FDA Product Code

GZT	Retractor, Self-Retaining, For Neurosurgery