← Back to catalogue

DoseRite

FDA UDI

Class I (US FDA UDI)

by Surgin Surgical Instrumentation, Inc.

Identity

Trade Name
DoseRite FDA UDI
Generic Name
Rectal medication applicator, reusable FDA UDI
Device Name
DoseRite Anal Fissure Pack, Reusable, Metric FDA UDI
Model / Reference
DRJ05AT-6 FDA UDI
Description
DoseRite Anal Fissure Pack, Reusable, Metric FDA UDI

Identifiers

Catalog Number
DRJ05AT-6 FDA UDI
Primary DI / UDI-DI
00850000610002 FDA UDI
FDA Product Code
KYZ FDA UDI
GMDN Term
Rectal medication applicator, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6960 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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, reusable

DoseRite by Surgin Surgical Instrumentation, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rectal medication applicator, reusable.

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
Surgin Surgical Instrumentation, Inc.

Sources (1)

  • FDA UDI aecab091-58c7-4ce7-8197-1a077ce85cf2 34 fields · synced May 29, 2026