AccessGUDID - DEVICE: Clear View Black Belt Extended Retractor System (10840199501882)

GUDID

Device Identifier (DI) Information

Brand Name: Clear View Black Belt Extended Retractor System
Version or Model: 7320-05T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7320-05T
Company Name: KOROS U.S.A., INC.

Primary DI Number: 10840199501882
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007928633 *Terms of Use

Device Description: "Radiolucent ClearView Black Belt Extended Retractor Set Consists of the Following: Set consists of: 1 7320-22T 1 ea Korpectomy Retractor Frame, Right 2 7320-20T 1 ea Retractor Frame, Left 3 7320-30T 1 ea Retractor Frame, Offset 4 7320-40T 2 ea Blade Inserting Clamps 5 7322-34T thru 70T 2 ea Pronged Ti Blades (14 total) 6 7324-34T thru 70T 2 ea Blunt Ti Blades (14 total) 7 7326-40T,-47T,-55T 4 ea Two-Level Ti Blades, Pronged 8 7328-40T,-47T,-55T 2 ea Two-Level Ti Blades, Blunt 9 7320-90T 1 ea Sterilizing Instrument Case with silicone inserts. 10 7321-10M 1 ea Microdiscectomy Adaptor 11 7321-20T 1 ea Spike Blade, 70 mm 12 7321-30T 1 ea T-Shape Blade, 70 mm 13 7321-40T 1 ea Inner Spine Ligament Blade, 70 mm 14 7322-85T 1 ea Pronged Ti Blade, 22x85 mm 15 7322-75T 1 ea 15 cm long Retractor Rack"

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: c0cb59f1-aa60-44dc-b16f-040a11e14604
Public Version Date: February 13, 2024
Public Version Number: 1
DI Record Publish Date: February 05, 2024