← Back to catalogue

Allura®

FDA UDI

Class II (US FDA UDI)

by Pmt Corp.

Identity

Trade Name
ALLURA® FDA UDI
Generic Name
Polymeric vaginal stent, non-bioabsorbable FDA UDI
Device Name
VAGINAL STENT, TAPERED CYLINDRICAL, SUTURE TABS, 4X14CM, 4CM PROJECTION, 140CC FILL FDA UDI
Model / Reference
3321-214-T FDA UDI
Description
VAGINAL STENT, TAPERED CYLINDRICAL, SUTURE TABS, 4X14CM, 4CM PROJECTION, 140CC FILL FDA UDI

Identifiers

Primary DI / UDI-DI
00650551002932 FDA UDI
510(k) Number
K202542 FDA UDI
FDA Product Code
KXP FDA UDI
GMDN Term
Polymeric vaginal stent, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.3900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Polymeric vaginal stent, non-bioabsorbable

Allura® by Pmt Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric vaginal stent, non-bioabsorbable.

Cleared under the same submission

K202542 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Pmt Corp.

Sources (1)

  • FDA UDI 6b68eebb-536c-40d1-81bf-d8ca63f2b16f 34 fields · synced May 30, 2026