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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
size 0 capsule suppository applicator, 6 total FDA UDI
Model / Reference
D0-6 FDA UDI
Description
size 0 capsule suppository applicator, 6 total FDA UDI

Identifiers

Primary DI / UDI-DI
00850325006429 FDA UDI
FDA Product Code
OOW FDA UDI
HGD FDA UDI
GMDN Term
Rectal medication applicator, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.4730 FDA UDI
884.4520 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

Yes

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cristcot LLC

Sources (1)

  • FDA UDI 97627ccc-d598-4dba-ab08-a174262bd899 34 fields · synced May 30, 2026