AccessGUDID - DEVICE: Premarin (conjugated estrogens) vaginal cream (00300460872040)

GUDID

Device Identifier (DI) Information

Brand Name: Premarin (conjugated estrogens) vaginal cream
Version or Model: NDC 0046-0872-04
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WYETH PHARMACEUTICALS LLC

Primary DI Number: 00300460872040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113008515 *Terms of Use

Device Description: Premarin Vaginal Cream Applicator - Sample

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
32652	Vaginal applicator, reusable	A device designed to apply medication to the vagina. It is typically a hand-held bulb, pump, or injector used to introduce medicated powder or other substances into the vagina either directly or through an open speculum. It is typically used to treat vaginitis but can be used for other forms of vaginal treatment. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGD	APPLICATOR, VAGINAL

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: No
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: 2cb03cfa-447d-40ee-ac69-bf6c9df44821
Public Version Date: December 17, 2020
Public Version Number: 2
DI Record Publish Date: September 24, 2020