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Pediatric Anal Dilator

FDA UDI

Class I (US FDA UDI)

by Specialty Surgical Products, Inc.

Identity

Trade Name
Pediatric Anal Dilator FDA UDI
Generic Name
Rectal dilator, single-use FDA UDI
Device Name
Pediatric Anal Dilator, 16mm size, Single Patient-Multiple Use, Non-Sterile FDA UDI
Model / Reference
PAD16 FDA UDI
Description
Pediatric Anal Dilator, 16mm size, Single Patient-Multiple Use, Non-Sterile FDA UDI

Identifiers

Catalog Number
PAD16 FDA UDI
Primary DI / UDI-DI
M746PAD169 FDA UDI
FDA Product Code
FFP FDA UDI
GMDN Term
Rectal dilator, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5450 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

Yes

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 dilator, single-use

Pediatric Anal Dilator by Specialty Surgical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rectal dilator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Specialty Surgical Products, Inc.

Sources (1)

  • FDA UDI 0a981d45-1f05-4d71-b620-c8e4d56c3cda 36 fields · synced May 31, 2026