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Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Pulmonary dilator FDA UDI
Device Name
PRATT Uterine Dilators. Solid, double-ended. Mirror finish. Overall length 11-3/8in (28.9cm). Size 37-39Fr FDA UDI
Model / Reference
31-1450-007 FDA UDI
Description
PRATT Uterine Dilators. Solid, double-ended. Mirror finish. Overall length 11-3/8in (28.9cm). Size 37-39Fr FDA UDI

Identifiers

Catalog Number
31-1450-007 FDA UDI
Primary DI / UDI-DI
00842180163751 FDA UDI
FDA Product Code
HDQ FDA UDI
GMDN Term
Pulmonary dilator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
884.4530 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Pulmonary dilator

The PRATT Uterine Dilators, a reliable and effective solution for obstetric care. Our double-ended solid dilators are designed with safety and comfort in mind, featuring a mirror finish and adjustable length to accommodate various uterine sizes.

Similar devices

Also classified as Pulmonary dilator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI e7f56989-b4c2-4983-bc6e-7aaec6682850 35 fields · synced Jul 29, 2026