AccessGUDID - DEVICE: Skytron (10841736122522)

GUDID

Device Identifier (DI) Information

Brand Name: Skytron
Version or Model: 5-010-02-4B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5-010-02-4B
Company Name: SKYTRON LLC

Primary DI Number: 10841736122522
Issuing Agency: GS1
Commercial Distribution End Date: February 05, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 078375583 *Terms of Use

Device Description: 3/8 Inch X-RAY FT/LEG SECTION WITH CUT OUT

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):	No
Over the Counter (OTC):	Yes
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?
36606	Fluoroscopy/angiography table top	A component of a modular operating table designed as a detachable table top constructed for use during surgical procedures requiring fluoroscopic guidance, such as cardiovascular surgery and other interventional radiology procedures (e.g., biopsy). This table top is typically a one-piece, and completely flat construction with an x-ray translucent section(s) providing x-rays free of artefacts. It is not dedicated to breast biopsy, and not designed to position a patient during other specialist surgeries (i.e., it is not a specialist operating table top with x-ray transparent features).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQO	TABLE, OPERATING-ROOM, AC-POWERED

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
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65263b1f-544c-47af-b048-fc9feed61718
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: January 29, 2022