AccessGUDID - DEVICE: Impoaid (00850358007097)

GUDID

Device Identifier (DI) Information

Brand Name: Impoaid
Version or Model: Ring Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 44023-001
Company Name: ENCORE, INC.

Primary DI Number: 00850358007097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 614647725 *Terms of Use

Device Description: Ring Kit

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):	No
Over the Counter (OTC):	Yes
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?
60659	Penile rigidity splint	A device intended to be worn externally on the penis of a patient affected by erectile dysfunction (ED) (commonly known as impotence) or premature ejaculation to support a flaccid penis during vaginal intercourse. It is typically comprised of a ring/loop worn at the base of the penis that connects, via a stabilizing rod, to another ring/loop worn at the head of the penis; it may also be intended to stimulate a penile erection. It is manufactured with specific characteristics (e.g., length, diameter) for a specified patient (i.e., custom-made) and lubricant may be included. This is a reusable device after appropriate cleaning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKY	Device, External Penile Rigidity

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: 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: 2cc8f6d1-d9ff-4de2-b942-93fe67c1b40c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016

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: No Unit of Use DI Numbers Found 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-475-3091
Email: info@revivepremium.com

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