AccessGUDID - DEVICE: Imperial Staddle (Neurosurgery) Tables (07540162041280)

GUDID

Device Identifier (DI) Information

Brand Name: Imperial Staddle (Neurosurgery) Tables
Version or Model: OR-3646F-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OR-3646F-A
Company Name: Imperial Surgical Ltd

Primary DI Number: 07540162041280
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 245253575 *Terms of Use

Device Description: 34" x 24" Straddle Table w/Std crank hdl & 4-sided Flanged sides

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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?
13959	Instrument table	A table used for laying out sterile surgical instruments, sutures, and other utensils/items required during an operation or intervention. It is designed to include an appropriate, e.g., stainless steel, top or surface with no crevices, screws or rivets, and most tables include telescoping pedestals for height adjustment and swivel caster bases. This table is used in the so-called "sterile area" of the operation site and in some cases may be attached to the operating table.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZM	Stool, Operating-Room

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: 9eb1c152-66f3-4e74-8f0b-e75fb9412e81
Public Version Date: January 22, 2021
Public Version Number: 1
DI Record Publish Date: January 14, 2021