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Surgical Speculums

FDA UDI

Class I (US FDA UDI)

by Timesco Healthcare Limited

Identity

Trade Name
Surgical Speculums FDA UDI
Generic Name
Rectal speculum FDA UDI
Device Name
Eisenhammer Rectal Speculum 8"(20cm) S/R FDA UDI
Model / Reference
53.600.10 FDA UDI
Description
Eisenhammer Rectal Speculum 8"(20cm) S/R FDA UDI

Identifiers

Primary DI / UDI-DI
05055382837190 FDA UDI
FDA Product Code
FFQ FDA UDI
GMDN Term
Rectal speculum FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.4730 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: Rectal speculum

Surgical Speculums by Timesco Healthcare Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rectal speculum.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Timesco Healthcare Limited

Sources (1)

  • FDA UDI d9af392a-38ae-47c8-a4af-dd00fc3b1d66 34 fields · synced May 30, 2026