AccessGUDID - DEVICE: Mitral Valve Retractor/Sternum Spreader (10840199544469)

GUDID

Device Identifier (DI) Information

Brand Name: Mitral Valve Retractor/Sternum Spreader
Version or Model: 8800-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8800-50
Company Name: KOROS U.S.A., INC.

Primary DI Number: 10840199544469
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007928633 *Terms of Use

Device Description: Mitral Valve Retractor/Sternum Spreader Consists of the Following: 1 x 8750-28, 1 x 8800-502, 1 x 8800-503, 2 x 8800-504, 2 x 8800-505, 1 x 8800-506, 1 x 8800-507, 1 x 8800-508, 1 x 8800-509, 1 x 8800-510, 1 x 8800-511, 1 x 8800-512 & 1 x 8800-513

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dry place at room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 9x12mm

Device Record Status

Public Device Record Key: 1634b8dc-b57e-4c66-9758-87a3244803bf
Public Version Date: November 08, 2022
Public Version Number: 1
DI Record Publish Date: October 31, 2022