AccessGUDID - DEVICE: C-Thru (00810045920320)

GUDID

Device Identifier (DI) Information

Brand Name: C-Thru
Version or Model: C-Thru Adult Armboard
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C-902717-CUSTOM - 11" x 25" x 11"
Company Name: INSTRUMENT SPECIALISTS, INC.

Primary DI Number: 00810045920320
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041517095 *Terms of Use

Device Description: C-Thru Adult Armboard, 11" Long one end x 25" Long on other x 11" Wide

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
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?
36608	Orthopaedic operating table top	A component of a modular operating table designed as a detachable table top to support a patient during orthopaedic surgical procedures. Its surface consists of articulated sections that can be adjusted; it might be intended to provide traction, and may have x-ray transparent features. It is often intended to be used with additional patient positioners.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSE	Table, Operating-Room, Manual

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 4dbe10a9-c8ba-45d4-8bb5-193299cc679b
Public Version Date: July 31, 2020
Public Version Number: 1
DI Record Publish Date: July 23, 2020