AccessGUDID - DEVICE: Centurion (10653160294153)

GUDID

Device Identifier (DI) Information

Brand Name: Centurion
Version or Model: PS276MSOST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PS276MSOST
Company Name: CENTURION MEDICAL PRODUCTS CORPORATION

Primary DI Number: 10653160294153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017246562 *Terms of Use

Device Description: ST PEDERSON SPEC MED SIDE OPEN-PS276MSO

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?
37468	Vaginal speculum, single-use	A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDF	SPECULUM, VAGINAL, METAL

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: 22aeebeb-492f-472c-9798-dfc902a26145
Public Version Date: January 10, 2022
Public Version Number: 1
DI Record Publish Date: January 02, 2022