AccessGUDID - DEVICE: NA (04715309125250)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: BA100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PANPAC MEDICAL CORPORATION

Primary DI Number: 04715309125250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657528899 *Terms of Use

Device Description: The Uterine Sound is used to gauge the depth and position of the uterine cavity. It is also helpful with the placement of IUDs and the verification of the intrauterine position and length for HSG procedures. The proximal portion of the sound is 3.5 mm in diameter tapering to 2.5 mm at the distal portion with a bulbous tip to reduce the risk of perforation. Malleable to adapt to anatomical variations.It is a sterile, disposable, single-use only 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":	Yes
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?
46435	Uterine sound, single-use	A sterile, hand-held manual instrument designed to measure and/or explore the internal depth or length of the uterus, cervix, and/or vagina. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHM	Sound, Uterine

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: ba5d7038-b9b5-43e8-aeed-ed75cb537686
Public Version Date: June 25, 2020
Public Version Number: 3
DI Record Publish Date: August 15, 2016