AccessGUDID - DEVICE: PullUp Surgical Probe Cover Kit (00841912100095)

GUDID

Device Identifier (DI) Information

Brand Name: PullUp Surgical Probe Cover Kit
Version or Model: 2002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2002EUR
Company Name: PROTEK MEDICAL PRODUCTS, INC.

Primary DI Number: 00841912100095
Issuing Agency: GS1
Commercial Distribution End Date: February 14, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 965417181 *Terms of Use

Device Description: No description.

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:	Yes
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?
44714	Intraoperative ultrasound imaging transducer cover	A sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. 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 [?]
K970889	000
K970893	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 7d4f9afb-5884-4f5c-9b3b-3708d922866e
Public Version Date: May 17, 2021
Public Version Number: 6
DI Record Publish Date: September 16, 2016