AccessGUDID - DEVICE: Black Belt Legend All Titanium Basic Retractor System (10840199504401)

GUDID

Device Identifier (DI) Information

Brand Name: Black Belt Legend All Titanium Basic Retractor System
Version or Model: 7320-00PT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7320-00PT
Company Name: KOROS U.S.A., INC.

Primary DI Number: 10840199504401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007928633 *Terms of Use

Device Description: Black Belt Legend All Titanium Basic Retractor System, Consists of the Following: 1x 7320-22P - Korpectomy Ti Retractor frame Right 1x 7320-20P - Ti Retractor frame Left 1x 7320-30P - Ti Retractor frame Offset 1x 7320-35P - Black Belt Legend Screwdriver 2x 7320-40M - Ti Blade Inserting Clamps 2x 7322-34M - Pronged Ti Blade 34mm, 2x 7322-40M - Pronged Ti Blade 40mm, 2x 7322-45M - Pronged Ti Blade 45mm, 2x 7322-50M - Pronged Ti Blade 50mm, 2x 7322-55M - Pronged Ti Blade 55mm, 2x 7322-60M - Pronged Ti Blade 60mm, 2x 7322-70M - Pronged Ti Blade 70mm, 2x 7324-34M - Blunt Ti Blade 34mm, 2x 7324-40M - Blunt Ti Blade 40mm, 2x 7324-45M - Blunt Ti Blade 45mm, 2x 7324-50M - Blunt Ti Blade 50mm, 2x 7324-55M - Blunt Ti Blade 55mm, 2x 7324-60M - Blunt Ti Blade 60mm, 2x 7324-70M - Blunt Ti Blade 70mm, 4x 7326-40M - Two-Level Ti Blade Pronged 40mm, 4x 7326-47M - Two-Level Ti Blade Pronged 47mm, 4x 7326-55M - Two-Level Ti Blade Pronged 55mm, 2x 7328-40M - Two-Level Ti Blade Blunt 40mm, 2x 7328-47M - Two-Level Ti Blade Blunt 47mm, 2x 7328-55M - Two-Level Ti Blade Blunt 55mm, 1x 7320-90M - Sterilizing Instrument Case with silicone pads

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:	Yes
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
GZT	Retractor, Self-Retaining, For Neurosurgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K935529	000

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 247fc427-e4cc-47cf-8a0b-ac7d3cd4d780
Public Version Date: November 08, 2022
Public Version Number: 1
DI Record Publish Date: October 31, 2022