MSI Precision Specialty Instruments

FDA UDI

Class I (US FDA UDI)

by Med Saver, Inc.

Identity

Trade Name: MSI Precision Specialty Instruments FDA UDI
Generic Name: Rectal speculum FDA UDI
Device Name: Hinkle-James Rectal Speculum, Tapered From 16mm To 51mm (5/8" To 2"), Overall Length 4-3/8" (111mm) FDA UDI
Model / Reference: 91-3385SK FDA UDI
Description: Hinkle-James Rectal Speculum, Tapered From 16mm To 51mm (5/8" To 2"), Overall Length 4-3/8" (111mm) FDA UDI

Identifiers

Primary DI / UDI-DI: 00194613065607 FDA UDI
FDA Product Code: FXE FDA UDI
GMDN Term: Rectal speculum FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.1800 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rectal speculum

MSI Precision Specialty Instruments by Med Saver, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Med Saver, Inc.

Sources (1)

FDA UDI 9eaf0b2b-eef8-42e5-bdf3-81e7104131bf 34 fields · synced May 31, 2026