AccessGUDID - DEVICE: Universal Clamp (10817121000287)

GUDID

Device Identifier (DI) Information

Brand Name: Universal Clamp
Version or Model: 1100347
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1100347
Company Name: Coroneo Inc

Primary DI Number: 10817121000287
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 255276362 *Terms of Use

Device Description: The device is intended to be used to clamp surgical instruments to the adult thoracic retractors manufactured by CORONEO INC.

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?
64146	Surgical instrument assist arm system structural component	A connecting component of a surgical instrument assist arm system intended to be integrated as part of the structural assembly of the arm. It is a structural component (not a repair tool) and may be in the form of an arm piece/rod, base unit, clamp, actuator, or instrument holding component; it is not intended to be used as the distal tissue interfacing instrument. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a6204ff6-4df4-4834-9df4-0ed18669a6d7
Public Version Date: October 07, 2022
Public Version Number: 1
DI Record Publish Date: September 29, 2022