AccessGUDID - DEVICE: NA (04715309125007)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: OS265BA-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PANPAC MEDICAL CORPORATION

Primary DI Number: 04715309125007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657528899 *Terms of Use

Device Description: These Cervical Dilators are especially useful in locating and dilating the external OS, the cervical canal and the internal OS. They are particularly valuable instruments to be used on post-menopausal patients with cervical stenosis.

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?
58389	Corpus cavernosum dilator, single-use	A sterile, hand-held, manual surgical instrument designed to dilate the corpora cavernosa of the penis prior to the insertion of a penile prosthesis. The device is rod-like in design and typically made of plastic; it is available in a set of graduated sizes that are applied in succession. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDQ	Dilator, Cervical, Fixed Size

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: f9a8f82b-2026-4427-ae9c-d47993adb162
Public Version Date: June 25, 2020
Public Version Number: 3
DI Record Publish Date: August 15, 2016