AccessGUDID - DEVICE: X-RAY FOOT/LEG SECTION (10841736113049)

GUDID

Device Identifier (DI) Information

Brand Name: X-RAY FOOT/LEG SECTION
Version or Model: 5-010-09-4B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SKYTRON LLC

Primary DI Number: 10841736113049
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" X-RAY FT/LEG SECT. 3500/6500

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?
37255	Universal operating table top	A component of a modular operating table designed as a detachable table top that can be adjusted to support a patient during many types of surgical interventions. It may consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or intended to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5809ab57-7f9a-4502-9c19-c664bcea5832
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: October 15, 2019