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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
Middle ear pick FDA UDI
Device Name
Penfield dissector, 7 1/4'', double-ended, size #2, slightly curved dissector, wax packer, flat handle FDA UDI
Model / Reference
Penfield dissector FDA UDI
Description
Penfield dissector, 7 1/4'', double-ended, size #2, slightly curved dissector, wax packer, flat handle FDA UDI

Identifiers

Catalog Number
44-051 FDA UDI
Primary DI / UDI-DI
00190660107093 FDA UDI
FDA Product Code
GDI FDA UDI
GMDN Term
Middle ear pick FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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: Middle ear pick

Ambler Value Line by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Middle ear pick.

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 2def37fe-e5c3-41b9-b2c9-08c8e95448e6 35 fields · synced May 30, 2026