AccessGUDID - DEVICE: Drape, sterile for motor or footswitch (Straub Medical®) (07640142810193)

GUDID

Device Identifier (DI) Information

Brand Name: Drape, sterile for motor or footswitch (Straub Medical®)
Version or Model: Version 1.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 80068
Company Name: Straub Medical AG

Primary DI Number: 07640142810193
Issuing Agency: GS1
Commercial Distribution End Date: January 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 488489766 *Terms of Use

Device Description: The plastic sleeve is used to cover and keep the handle/motor or footswitch clean and allows the motor to enter the sterile field.

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:	Yes
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?
12535	Medical equipment/instrument drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KKX	Drape, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Outer Diameter: 18.5 Centimeter
Length: 340 Centimeter

Device Record Status

Public Device Record Key: ef22f639-44de-4fad-a4c3-3309108dcbfd
Public Version Date: January 29, 2025
Public Version Number: 6
DI Record Publish Date: January 31, 2020