AccessGUDID - DEVICE: Black Belt Extended Retractor System All Titanium (10840199501844)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 10840199501844
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007928633 *Terms of Use

Device Description: Black Belt Extended Retractor System All Titanium Consists of the following: 1x 7320-22M - Korpectomy Retractor Frame Right, 1x 7320-20M - Retractor Frame Left, 1x 7320-30M - Retractor Frame Offset, 2x 7320-40M - Blade Inserting Clamps, 2x 7322-34M - Pronged Ti Blades, 2x 7322-40M - Pronged Ti Blades, 2x 7322-45M - Pronged Ti Blades, 2x 7322-50M - Pronged Ti Blades, 2x 7322-55M - Pronged Ti Blades, 2x 7322-60M - Pronged Ti Blades, 2x 7322-70M - Pronged Ti Blades, 2x 7324-34M - Blunt Ti Blades, 2x 7324-40M - Blunt Ti Blades, 2x 7324-45M - Blunt Ti Blades, 2x 7324-50M - Blunt Ti Blades, 2x 7324-55M - Blunt Ti Blades, 2x 7324-60M - Blunt Ti Blades, 2x 7324-70M - Blunt Ti Blades, 4x 7326-40M - Two-Level Ti Blades Pronged, 4x 7326-47M - Two-Level Ti Blades Pronged, 4x 7326-55M - Two-Level Ti Blades Pronged, 2x 7328-40M - Two-Level Ti Blades Blunt, 2x 7328-47M - Two-Level Ti Blades Blunt, 2x 7328-55M - Two-Level Ti Blades Blunt, 1x 7320-90M - Sterilizing Instrument Case with silicone inserts, 1x 7321-10M - Microdiscectomy Adaptor, 1x 7321-20M - Spike Blade 70 mm, 1x 7321-30M - T-Shape Blade 70mm, 1x 7321-40M - Inner Spine Ligament Blade 70mm, 1x 7322-85M - Pronged Ti Blade 22x85mm, 1x 7322-75M - 15cm 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: 9328da5e-06ec-4fb5-af27-b9346bb439c6
Public Version Date: July 22, 2021
Public Version Number: 1
DI Record Publish Date: July 14, 2021