AccessGUDID - DEVICE: STERIS (00724995155636)

GUDID

Device Identifier (DI) Information

Brand Name: STERIS
Version or Model: OT 1100 Orthopedic Table
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10008320
Company Name: STERIS CORPORATION

Primary DI Number: 00724995155636
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The STERIS OT 1100 Series Orthopedic Surgical Table performs a variety of orthopedic procedures, including anterior hips, maximizing operational efficiency while maintaining patient and staff safety.

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?
38740	Orthopaedic operating table, electrohydraulic	A mobile, mains electricity (AC-powered) hydraulic-mechanism table designed to support a patient and to provide traction for the limb(s) of the patient (upper or lower extremity) during orthopaedic surgical procedures. Its surface consists of sections that can be height-adjusted in relation to the section supporting the patient's trunk, and the sections that initially support the legs which are lowered once the patient has been placed in traction. Broken bones can be drawn apart, repositioned, and set to the correct position.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEA	TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, 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: f2e56520-a35a-42e4-9c59-b72d5fe02102
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021