Digisert

FDA UDI

Class I (US FDA UDI)

by Therafin Corporation

Identity

Trade Name: Digisert FDA UDI
Generic Name: Rectal medication applicator, reusable FDA UDI
Device Name: DIGI-SERT, EZ REACH FDA UDI
Model / Reference: 30511 FDA UDI
Description: DIGI-SERT, EZ REACH FDA UDI

Identifiers

Catalog Number: 30511 FDA UDI
Primary DI / UDI-DI: 00840252905834 FDA UDI
FDA Product Code: ILS FDA UDI
GMDN Term: Rectal medication applicator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Rectal medication applicator, reusable

Digisert by Therafin Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rectal medication applicator, reusable.

DoseRite — SURGIN SURGICAL INSTRUMENTATION, INC. · Class I
DoseRite — SURGIN SURGICAL INSTRUMENTATION, INC. · Class I
DoseRite — SURGIN SURGICAL INSTRUMENTATION, INC. · Class I
DoseRite — SURGIN SURGICAL INSTRUMENTATION, INC. · Class I
DoseRite — SURGIN SURGICAL INSTRUMENTATION, INC. · Class I
Digisert — Therafin Corporation · Class I
Digisert — Therafin Corporation · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: Therafin Corporation

Sources (1)

FDA UDI 89183653-6e18-411a-bde7-1de6eaed871e 35 fields · synced May 29, 2026