AccessGUDID - DEVICE: P&P Medical Surgical LLC (G026009501)

GUDID

Device Identifier (DI) Information

Brand Name: P&P Medical Surgical LLC
Version or Model: 00950
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: P&P Medical Surgical LLC

Primary DI Number: G026009501
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022925151 *Terms of Use

Device Description: Disposable Medical Exam Table Paper Standard Crepe White with Smooth Finish Moisture Resistant 21" x 225' Premium Lightweight and Comfortable Box of 1 Roll

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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?
35880	Examination/treatment table paper	A non-sterile sheet made of paper intended to cover the surface of an examination/treatment table, or chair, during use to function as a barrier between the table top and the patient to maintain hygienic conditions. It is typically supplied in a roll designed to be mounted at one end of the table such that a new length of paper can be pulled down over the table top for each new patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMN	Chair And Table, Medical

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: 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: a7a6021d-4d7b-40a6-a808-9eeeac1fcd96
Public Version Date: February 22, 2022
Public Version Number: 1
DI Record Publish Date: February 14, 2022