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.
7320-00PT
In Commercial Distribution
7320-00PT
KOROS U.S.A., INC.
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
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GZT | Retractor, Self-Retaining, For Neurosurgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K935529 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in dry place at room temperature |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
247fc427-e4cc-47cf-8a0b-ac7d3cd4d780
November 08, 2022
1
October 31, 2022
November 08, 2022
1
October 31, 2022
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-805-529-0825
customerservice@korosUSA.com
customerservice@korosUSA.com