DEVICE: Black Belt II Tilting Arm Retractor Basic Set All Titanium (10840199501783)

Device Identifier (DI) Information

Black Belt II Tilting Arm Retractor Basic Set All Titanium
7320-00MU
In Commercial Distribution
7320-00MU
KOROS U.S.A., INC.
10840199501783
GS1

1
007928633 *Terms of Use
Black Belt II Tilting Arm Retractor Basic Set All Titanium, Consists of the Following: 1x 7320-10TU - Black Belt II Ti Tilting Arm Retractor Frame Right, 1x 7320-20TU - Black Belt II Ti Tilting Arm Retractor Frame Left, 1x 7320-30TU - Black Belt II Ti Tilting Arm Retractor Frame Offset, 2x 7320-40M - Black Belt Retractor Blade Inserting Clamp SST, 2x 7322-34M - Black Belt Ti Blade Pronged 34mm, 2x 7322-40M - Black Belt Ti Blade Pronged 40mm, 2x 7322-45M - Black Belt Ti Blade Pronged 45mm, 2x 7322-50M - Black Belt Ti Blade Pronged 50mm, 2x 7322-55M - Black Belt Ti Blade Pronged 55mm, 2x 7322-60M - Black Belt Ti Blade Pronged 60mm, 2x 7322-70M - Black Belt Ti Blade Pronged 70mm, 2x 7324-34M - Black Belt Ti Blade Blunt 34mm, 2x 7324-40M - Black Belt Ti Blade Blunt 40mm, 2x 7324-45M - Black Belt Ti Blade Blunt 45mm, 2x 7324-50M - Black Belt Ti Blade Blunt 50mm, 2x 7324-55M - Black Belt Ti Blade Blunt 55mm, 2x 7324-60M - Black Belt Ti Blade Blunt 60mm, 2x 7324-70M - Black Belt Ti Blade Blunt 70mm, 2x 7326-40M - BB Two-Level Ti Blade Pronged 40mm, 2x 7326-47M - BB Two-Level Ti Blade Pronged 47mm, 2x 7326-55M - BB Two-Level Ti Blade Pronged 55mm, 2x 7328-40M - BB Two-Level Ti Blade Blunt 40mm, 2x 7328-47M - BB Two-Level Ti Blade Blunt 47mm, 2x 7328-55M - BB Two-Level Ti Blade Blunt 55mm, 1x 7320-90M - Black Belt Retractor Instrument Case
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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

8c344d13-bf05-46bd-9d40-49c3e6a5bbd7
September 20, 2021
2
June 28, 2021
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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
00840199501786
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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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