Black Belt Extended Retractor System All Titanium 7320-05M

GUDID 00840199501847

Black Belt Extended Retractor System All Titanium Consists of the following: 1x 7320-22M - Korpectomy Retractor Frame Right, 1x 7320-20M - Retractor Frame Left, 1x 7320-30M - Retractor Frame Offset, 2x 7320-40M - Blade Inserting Clamps, 2x 7322-34M - Pronged Ti Blades, 2x 7322-40M - Pronged Ti Blades, 2x 7322-45M - Pronged Ti Blades, 2x 7322-50M - Pronged Ti Blades, 2x 7322-55M - Pronged Ti Blades, 2x 7322-60M - Pronged Ti Blades, 2x 7322-70M - Pronged Ti Blades, 2x 7324-34M - Blunt Ti Blades, 2x 7324-40M - Blunt Ti Blades, 2x 7324-45M - Blunt Ti Blades, 2x 7324-50M - Blunt Ti Blades, 2x 7324-55M - Blunt Ti Blades, 2x 7324-60M - Blunt Ti Blades, 2x 7324-70M - Blunt Ti Blades, 4x 7326-40M - Two-Level Ti Blades Pronged, 4x 7326-47M - Two-Level Ti Blades Pronged, 4x 7326-55M - Two-Level Ti Blades Pronged, 2x 7328-40M - Two-Level Ti Blades Blunt, 2x 7328-47M - Two-Level Ti Blades Blunt, 2x 7328-55M - Two-Level Ti Blades Blunt, 1x 7320-90M - Sterilizing Instrument Case with silicone inserts, 1x 7321-10M - Microdiscectomy Adaptor, 1x 7321-20M - Spike Blade 70 mm, 1x 7321-30M - T-Shape Blade 70mm, 1x 7321-40M - Inner Spine Ligament Blade 70mm, 1x 7322-85M - Pronged Ti Blade 22x85mm, 1x 7322-75M - 15cm long Retractor Rack.

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
Primary Device ID00840199501847
NIH Device Record Key9328da5e-06ec-4fb5-af27-b9346bb439c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlack Belt Extended Retractor System All Titanium
Version Model Number7320-05M
Catalog Number7320-05M
Company DUNS007928633
Company NameKOROS U.S.A., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840199501847 [Direct Marking]
GS110840199501844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZTRetractor, Self-Retaining, For Neurosurgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


[00840199501847]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

Devices Manufactured by KOROS U.S.A., INC.

00840199501847 - Black Belt Extended Retractor System All Titanium 2021-07-22Black Belt Extended Retractor System All Titanium Consists of the following: 1x 7320-22M - Korpectomy Retractor Frame Right, 1x 7320-20M - Retractor Frame Left, 1x 7320-30M - Retractor Frame Offset, 2x 7320-40M - Blade Inserting Clamps, 2x 7322-34M - Pronged Ti Blades, 2x 7322-40M - Pronged Ti Blades, 2x 7322-45M - Pronged Ti Blades, 2x 7322-50M - Pronged Ti Blades, 2x 7322-55M - Pronged Ti Blades, 2x 7322-60M - Pronged Ti Blades, 2x 7322-70M - Pronged Ti Blades, 2x 7324-34M - Blunt Ti Blades, 2x 7324-40M - Blunt Ti Blades, 2x 7324-45M - Blunt Ti Blades, 2x 7324-50M - Blunt Ti Blades, 2x 7324-55M - Blunt Ti Blades, 2x 7324-60M - Blunt Ti Blades, 2x 7324-70M - Blunt Ti Blades, 4x 7326-40M - Two-Level Ti Blades Pronged, 4x 7326-47M - Two-Level Ti Blades Pronged, 4x 7326-55M - Two-Level Ti Blades Pronged, 2x 7328-40M - Two-Level Ti Blades Blunt, 2x 7328-47M - Two-Level Ti Blades Blunt, 2x 7328-55M - Two-Level Ti Blades Blunt, 1x 7320-90M - Sterilizing Instrument Case with silicone inserts, 1x 7321-10M - Microdiscectomy Adaptor, 1x 7321-20M - Spike Blade 70 mm, 1x 7321-30M - T-Shape Blade 70mm, 1x 7321-40M - Inner Spine Ligament Blade 70mm, 1x 7322-85M - Pronged Ti Blade 22x85mm, 1x 7322-75M - 15cm long Retractor Rack.
00840199501847 - Black Belt Extended Retractor System All Titanium 2021-07-22 Black Belt Extended Retractor System All Titanium Consists of the following: 1x 7320-22M - Korpectomy Retractor Frame Right, 1x
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00840199501908 - ClearView Tilting Arm Black Belt II Extended Retractor Set2021-07-22 ClearView Tilting Arm Black Belt II Extended Retractor Set
00840199501915 - Tilting Arm Black Belt II Extended Retractor Set2021-07-22 Tilting Arm Black Belt II Extended Retractor Set
00840199501922 - Ti Colored Black Belt Depth Gauge2021-07-22 Ti Colored Black Belt Depth Gauge
00840199501939 - Black Belt Retractor Frame Right2021-07-22 Black Belt Retractor Frame Right
00840199501946 - Ti Black Belt Retractor Frame Right2021-07-22 Titanium Black Belt Retractor Frame Right
00840199501953 - ClearView Korpectomy Retractor Frame Right2021-07-22 ClearView Korpectomy Retractor Frame Right

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