AccessGUDID - DEVICE: ALLURA (00650551002758)

GUDID

Device Identifier (DI) Information

Brand Name: ALLURA
Version or Model: 3321-212-X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PMT CORPORATION

Primary DI Number: 00650551002758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039576871 *Terms of Use

Device Description: VAGINAL STENT, TAPERED CYLINDRICAL, 4 SUTURE TABS "X" LOCATION, 4X12CM, 4CM PROJECTION, 115CC FILL

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):	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?
51084	Polymeric vaginal stent, non-bioabsorbable	A sterile non-bioabsorbable tubular device intended for long-term placement in the vagina to provide structural support and/or prevent shrinking. It is typically used for vaginal dilation following surgical or non-surgical treatment of vaginal agenesis or transgender vaginoplasty, or for the prevention of vaginal contracture or stenosis after radiotherapy. It is made of a synthetic polymer(s) [e.g., silicone] and may have various designs (e.g., inflatable tubular envelope with valves and internal drains, semi-soft moulded tube). This is a single-patient use device that can be reapplied to the patient during the treatment period (e.g., nightly) before being discarded (reusable).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KXP	Stent, Vaginal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202542	000

Device Exempt from Premarket Submission: No 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: 9a9f18fc-578c-4964-a9fa-bb5bcea3046f
Public Version Date: November 04, 2021
Public Version Number: 1
DI Record Publish Date: October 27, 2021