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Ambler Value Line

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name
Ambler Value Line FDA UDI
Generic Name
Rectal speculum FDA UDI
Device Name
Pratt rectal speculum, 8 1/2'', 3 1/2'' long x 1'' diameter, with set screw FDA UDI
Model / Reference
Pratt rectal speculum FDA UDI
Description
Pratt rectal speculum, 8 1/2'', 3 1/2'' long x 1'' diameter, with set screw FDA UDI

Identifiers

Catalog Number
186-595 FDA UDI
Primary DI / UDI-DI
00190660216733 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

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Rectal speculum

Ambler Value Line by Ambler Surgical, LLC — 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
Ambler Surgical, LLC

Sources (1)

  • FDA UDI 24ed2947-017e-4bee-9ae0-71e633f3a647 35 fields · synced May 30, 2026