AccessGUDID - DEVICE: NA (04715309125038)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: WC-400MM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PANPAC MEDICAL CORPORATION

Primary DI Number: 04715309125038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657528899 *Terms of Use

Device Description: The Word/Bartholin Catheter is used for the treatment of abscesses and cysts of the Bartholin gland.

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
42325	Cervical anaesthesia kit	A collection of sterile devices designed to deliver an analgesic or anaesthetic agent to function as an intracervical nerve-block and/or a paracervical regional nerve-block (sometimes including uterosacral and pudendal regions). It is typically used for gyneacological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery. It typically consists of a procedural needle, syringe, catheter, and a filter. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic

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
No Device Sizes

Device Record Status

Public Device Record Key: f5896f4b-2fbf-4b61-84c9-f9011a24276e
Public Version Date: November 07, 2022
Public Version Number: 5
DI Record Publish Date: August 15, 2016