← Back to catalogue

Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name
Ambler Surgical FDA UDI
Generic Name
Skin marking pen, reusable FDA UDI
Device Name
McKissock breast keyhole caliper, 38.0mm diameter, with cm marks FDA UDI
Model / Reference
McKissock breast keyhole caliper FDA UDI
Description
McKissock breast keyhole caliper, 38.0mm diameter, with cm marks FDA UDI

Identifiers

Catalog Number
14-157 FDA UDI
Primary DI / UDI-DI
00190660001988 FDA UDI
FDA Product Code
FZZ FDA UDI
GMDN Term
Skin marking pen, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4660 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: Skin marking pen, reusable

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

Similar devices

Also classified as Skin marking pen, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ambler Surgical, LLC

Sources (1)

  • FDA UDI b661db61-d792-4d37-9dac-f853a8b1b23a 35 fields · synced Jun 8, 2026