AccessGUDID - DEVICE: NA (00724995164669)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: BF807
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BF807
Company Name: STERIS CORPORATION

Primary DI Number: 00724995164669
Issuing Agency: GS1
Commercial Distribution End Date: January 13, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The OrthoVision Standard Accessory Package is used with STERIS OrthoVision Surgical Table.

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?
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
JEB	TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K905816	000

Device Exempt from Premarket Submission: No 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: 5f410e7d-470b-473b-8605-0f6f8a399bdc
Public Version Date: January 23, 2025
Public Version Number: 2
DI Record Publish Date: April 23, 2021