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Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name
Ambler Surgical FDA UDI
Generic Name
Middle ear pick FDA UDI
Device Name
Krayenbuehl nerve hook, 7 1/4'', straight, 1.8mm diameter twist hook, round handle without finger rest FDA UDI
Model / Reference
Krayenbuehl nerve hook FDA UDI
Description
Krayenbuehl nerve hook, 7 1/4'', straight, 1.8mm diameter twist hook, round handle without finger rest FDA UDI

Identifiers

Catalog Number
37-693 FDA UDI
Primary DI / UDI-DI
00190660085223 FDA UDI
FDA Product Code
GZX FDA UDI
GMDN Term
Middle ear pick FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4525 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

The Ambler Surgical Krayenbuehl nerve hook is a fine, hand-held manual surgical instrument designed for use in the middle ear. It features a unique design with a proximal handle tapering to a shaft that terminates in a fine distal tip.

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 aaec0534-e5db-40eb-ab3e-3d05a0406f5e 35 fields · synced Jul 27, 2026