AccessGUDID - DEVICE: Bard® Parsonnet Pulse Generator Pouches (00801741040962)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® Parsonnet Pulse Generator Pouches
Version or Model: 002905
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 002905
Company Name: Bard Peripheral Vascular, Inc.

Primary DI Number: 00801741040962
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 135057938 *Terms of Use

Device Description: Bard® Parsonnet Pulse Generator Pouch, Large

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?
16038	Implantable pulse generator mesh bag, non-bioabsorbable	An implantable woven/knitted or porous bag made from a non-bioabsorbable synthetic polymer(s) intended to envelop an implantable pulse generator (IPG) (e.g., cardiac pacemaker/defibrillator) to stabilize the implant in the subcutaneous pocket in which it is implanted; it does not contain an antimicrobial agent.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DSW	BAG, POLYMERIC MESH, PACEMAKER

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
Device Size Text, specify: Pouch Size, Large

Device Record Status

Public Device Record Key: a97eb98a-587b-4467-866e-291fcd75d372
Public Version Date: February 05, 2021
Public Version Number: 3
DI Record Publish Date: September 25, 2015