DEVICE: V-Type Retractor Set (10840199511256)

Device Identifier (DI) Information

V-Type Retractor Set
7310-10
In Commercial Distribution
7310-10
KOROS U.S.A., INC.
10840199511256
GS1

1
007928633 *Terms of Use
V-Type Retractor Set Consisting of the Following: 1 x 7310-20 V-Type Retractor Frame 4-1/2 long, 1 x 7316-40 Quick Change Blunt Blade 23 x 40mm, 1 x 7316-45 Quick Change Blunt Blade 23 x 45mm, 1 x 7316-50 Quick Change Blunt Blade 23 x 50mm, 1 x 7316-55 Quick Change Blunt Blade 23 x 55mm, 1 x 7316-60 Quick Change Blunt Blade 23 x 60mm
CLOSE

Device Characteristics

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

FDA Product Code

[?]
Product Code Product Code Name
GAD Retractor
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 6x12mm
CLOSE

Device Record Status

6f46c90b-9dd1-4daa-8b5a-def36e8e489f
September 09, 2021
1
September 01, 2021
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
Yes
00840199511259
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

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