DEVICE: Clearview Black Belt Retractor Starter Set (10840199501721)

Device Identifier (DI) Information

Clearview Black Belt Retractor Starter Set
7319-98T
In Commercial Distribution
7319-98T
KOROS U.S.A., INC.
10840199501721
GS1

1
007928633 *Terms of Use
Clearview Black Belt Retractor Starter Set Consists of the Following: Black Finish Stainless Steel Retractor Frames and Blue Finish Titanium Blades. 1x 7320-22T - Retractor frame Right 1x 7320-30T - Retractor frame Offset 2x 7320-40T - Blade Inserting Angled Clamps 2x 7322-34T - Pronged Blade Ti 34 mm, 2x 7322-40T - Pronged Blade Ti 40 mm, 2x 7322-45T - Pronged Blade Ti 45 mm, 2x 7322-50T - Pronged Blade Ti 50 mm, 2x 7322-55T - Pronged Blade Ti 55 mm, 2x 7322-60T - Pronged Blade Ti 60 mm, 2x 7324-34T - Blunt Blade Ti 34 mm, 2x 7324-40T - Blunt Blade Ti 40 mm, 2x 7324-45T - Blunt Blade Ti 45 mm, 2x 7324-50T - Blunt Blade Ti 50 mm, 2x 7324-55T - Blunt Blade Ti 55 mm, 2x 7324-60T - Blunt Blade Ti 60 mm, 1x 7319-90T - Sterilizing Instrument Case, 1.5 x 11 x 13"
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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
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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

37b44e79-b497-4850-8342-77b7daae0bd9
July 06, 2021
1
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
840199501724
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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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