DEVICE: Black Belt Legend All Titanium Basic Retractor System (10840199504401)

Device Identifier (DI) Information

Black Belt Legend All Titanium Basic Retractor System
7320-00PT
In Commercial Distribution
7320-00PT
KOROS U.S.A., INC.
10840199504401
GS1

1
007928633 *Terms of Use
Black Belt Legend All Titanium Basic Retractor System, Consists of the Following: 1x 7320-22P - Korpectomy Ti Retractor frame Right 1x 7320-20P - Ti Retractor frame Left 1x 7320-30P - Ti Retractor frame Offset 1x 7320-35P - Black Belt Legend Screwdriver 2x 7320-40M - Ti Blade Inserting Clamps 2x 7322-34M - Pronged Ti Blade 34mm, 2x 7322-40M - Pronged Ti Blade 40mm, 2x 7322-45M - Pronged Ti Blade 45mm, 2x 7322-50M - Pronged Ti Blade 50mm, 2x 7322-55M - Pronged Ti Blade 55mm, 2x 7322-60M - Pronged Ti Blade 60mm, 2x 7322-70M - Pronged Ti Blade 70mm, 2x 7324-34M - Blunt Ti Blade 34mm, 2x 7324-40M - Blunt Ti Blade 40mm, 2x 7324-45M - Blunt Ti Blade 45mm, 2x 7324-50M - Blunt Ti Blade 50mm, 2x 7324-55M - Blunt Ti Blade 55mm, 2x 7324-60M - Blunt Ti Blade 60mm, 2x 7324-70M - Blunt Ti Blade 70mm, 4x 7326-40M - Two-Level Ti Blade Pronged 40mm, 4x 7326-47M - Two-Level Ti Blade Pronged 47mm, 4x 7326-55M - Two-Level Ti Blade Pronged 55mm, 2x 7328-40M - Two-Level Ti Blade Blunt 40mm, 2x 7328-47M - Two-Level Ti Blade Blunt 47mm, 2x 7328-55M - Two-Level Ti Blade Blunt 55mm, 1x 7320-90M - Sterilizing Instrument Case with silicone pads
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45182 Self-retaining surgical retractor, reusable
A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GZT Retractor, Self-Retaining, For Neurosurgery
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K935529 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in dry place at room temperature
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

247fc427-e4cc-47cf-8a0b-ac7d3cd4d780
November 08, 2022
1
October 31, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
Yes
00840199504404
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
1-805-529-0825
customerservice@korosUSA.com
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