Tilting Arm Black Belt Retractor Starter Set 7319-98A

GUDID 00840199501717

Tilting Arm Black Belt Retractor Starter Set Consisting of the Following: 1x 7320-22A - Tilting Arm Retractor frame Right, 1x 7320-30A - Tilting Arm Retractor frame Offset, 2x 7320-40 - Blade Inserting Angled Clamp, 2x 7322-34 - Pronged Blade 34 mm, 2x 7322-40 - Pronged Blade 40 mm, 2x 7322-45 - Pronged Blade 45 mm, 2x 7322-50 - Pronged Blade 50 mm, 2x 7322-55 - Pronged Blade 55 mm, 2x 7322-60 - Pronged Blade 60 mm, 2x 7324-34 - Blunt Blade 34 mm, 2x 7324-40 - Blunt Blade 40 mm, 2x 7324-45 - Blunt Blade 45 mm, 2x 7324-50 - Blunt Blade 50 mm, 2x 7324-55 - Blunt Blade 55 mm, 2x 7324-60 - Blunt Blade 60 mm, 1x 7319-90 - Sterilizing Instrument Case, 1.5 x 11 x 13"

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

Primary Device ID	00840199501717
NIH Device Record Key	d36ee32e-bbe4-42f9-9349-e64cc65676e2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Tilting Arm Black Belt Retractor Starter Set
Version Model Number	7319-98A
Catalog Number	7319-98A
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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840199501717 [Direct Marking]
GS1	10840199501714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K935529

FDA Product Code

GZT	Retractor, Self-Retaining, For Neurosurgery