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Sephure® suppository applicator

FDA UDI

Class I (US FDA UDI)

by Cristcot LLC

Identity

Trade Name
Sephure® suppository applicator FDA UDI
Generic Name
Rectal medication applicator, single-use FDA UDI
Device Name
A2 10-pouch - rectal suppository applicator, USA FDA UDI
Model / Reference
A2-10 FDA UDI
Description
A2 10-pouch - rectal suppository applicator, USA FDA UDI

Identifiers

Primary DI / UDI-DI
00868648000031 FDA UDI
510(k) Number
K092829 FDA UDI
FDA Product Code
OOW FDA UDI
GMDN Term
Rectal medication applicator, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.4730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rectal medication applicator, single-use

Sephure® suppository applicator by Cristcot LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rectal medication applicator, single-use.

Cleared under the same submission

K092829 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cristcot LLC

Sources (1)

  • FDA UDI e4bea076-3c17-44ef-a1c4-8e11957250ab 35 fields · synced May 30, 2026