AccessGUDID - DEVICE: Malis Retractor Set (10840199508973)

GUDID

Device Identifier (DI) Information

Brand Name: Malis Retractor Set
Version or Model: 7244-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7244-10
Company Name: KOROS U.S.A., INC.

Primary DI Number: 10840199508973
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007928633 *Terms of Use

Device Description: Malis Retractor Set Consists of the Following: 1 x 7244-15 Malis Retractor Body Only, 1 x 7244-20 Malis Retractor Tower Attachment, 1 x 7244-25 Malis Retractor Swivel Clamp, 1 x 7244-30 Malis Retractor Arm Bar 9cm, 1 x 7244-35 Malis Retractor Arm Bar 12cm, 1 x 7244-40 Malis Retractor Arm Bar 15cm, 1 x 7244-45 Malis Retractor Blade 9x70mm, 1 x 7244-50 Malis Retractor Blade 14x70mm, 1 x 7244-55 Malis Retractor Blade 16x70mm, 1 x 7244-60 Malis Retractor Blade 19x70mm, 1 x 7244-65 Malis Retractor Blade 25x70mm, 1 x 7244-70 Malis Retractor Sterilizing Case

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: 6x12mm

Device Record Status

Public Device Record Key: ee90088d-e1ae-4433-a584-2b8814312d44
Public Version Date: September 09, 2021
Public Version Number: 1
DI Record Publish Date: September 01, 2021