AccessGUDID - DEVICE: Operon (07613327173918)

GUDID

Device Identifier (DI) Information

Brand Name: Operon
Version or Model: OT 1812075
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OT 1812075
Company Name: Berchtold Holding GmbH

Primary DI Number: 07613327173918
Issuing Agency: GS1
Commercial Distribution End Date: November 27, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 316153824 *Terms of Use

Device Description: Berchtold Surgical Table, D 752

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
35379	Universal operating table, electrohydraulic	A mobile, mains electricity (AC-powered) hydraulic-mechanism table designed to be adjusted to support a patient during many types of surgical interventions. The table surface 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) to satisfy the requirements of many clinical specialties.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDC	TABLE, OPERATING-ROOM, ELECTRICAL

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
Handling Environment Temperature: between -10 and 50 Degrees Celsius
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 52e4c988-4144-4f86-811b-b1a14f21f7b9
Public Version Date: November 28, 2022
Public Version Number: 3
DI Record Publish Date: August 21, 2019