AccessGUDID - DEVICE: PNEUMOSTOP® (00850012846017)

GUDID

Device Identifier (DI) Information

Brand Name: PNEUMOSTOP®
Version or Model: 110230
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110230
Company Name: LSI Solutions, Inc.

Primary DI Number: 00850012846017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 603420183 *Terms of Use
Previous DI: 00850200006759

Device Description: PNEUMOSTOP® PLUS DEVICE

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?
64599	Laparoscopic hysterectomy vaginal occluder	A semi-soft device designed to be inserted into the vagina to maintain pneumoperitoneum during removal of the uterus during laparoscopic hysterectomy. It is in the form of a cylinder with ridges and is made of synthetic polymer materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWW	Hysteroscope accessories

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: 046da86e-0bd6-4c40-8d09-555f56833f10
Public Version Date: November 14, 2022
Public Version Number: 1
DI Record Publish Date: November 04, 2022