AccessGUDID - DEVICE: REVAREE (08032595871064)

GUDID

Device Identifier (DI) Information

Brand Name: REVAREE
Version or Model: VAGINAL SUPPOSITORIES 2 g
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FARMA DERMA SRL

Primary DI Number: 08032595871064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 541677746 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	No
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?
47673	Vaginal mucosa protection suppository	A device in the form of a tablet, ovule or gel that is inserted into the vagina containing compounds [e.g., hyaluronic acid (HA), plant oil extracts, vitamins] intended to promote and/or expedite the healing, re-epithelialization, and/or soothing of injured, atrophic, or irritated vaginal mucosa through various mechanisms (e.g., osmotic properties, lubrication). It is typically used for procedure-related injury (e.g., after childbirth, surgery, radiation), age-related dryness, or various pathologies (e.g., vulvovaginitis). It is intended for use in the home or healthcare facility. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NUC	Lubricant, Personal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153372	000

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: 807d4b01-84c8-4ee8-95c7-f046b89d0e63
Public Version Date: August 20, 2020
Public Version Number: 4
DI Record Publish Date: February 26, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 08032595871088 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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