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Synalax

FDA UDI

Class I (US FDA UDI)

by Cristcot LLC

Identity

Trade Name
Synalax FDA UDI
Generic Name
Rectal medication applicator, single-use FDA UDI
Device Name
Synalax 3 pack with 3 Sephure suppository applicators FDA UDI
Model / Reference
Synalax FDA UDI
Description
Synalax 3 pack with 3 Sephure suppository applicators FDA UDI

Identifiers

Primary DI / UDI-DI
00850325006405 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

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

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

Synalax 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 5519b8b0-3b65-4560-a0a8-75ba2bbe3fd9 35 fields · synced Jun 1, 2026