← Back to catalogue

Ambler Surgical

FDA UDI

Class II (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name
Ambler Surgical FDA UDI
Generic Name
Surgical self-retaining retractor, reusable FDA UDI
Device Name
Bookwalter Meyerding retractor, 2/3" x 2 1/3" blade, with toothed end FDA UDI
Model / Reference
70-670 FDA UDI
Description
Bookwalter Meyerding retractor, 2/3" x 2 1/3" blade, with toothed end FDA UDI

Identifiers

Catalog Number
70-670 FDA UDI
Primary DI / UDI-DI
00190660132200 FDA UDI
510(k) Number
K071771 FDA UDI
FDA Product Code
GZT FDA UDI
GMDN Term
Surgical self-retaining retractor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4800 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

No

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: Surgical self-retaining retractor, reusable

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

Similar devices

Also classified as Surgical self-retaining retractor, reusable.

Cleared under the same submission

K071771 also covers:

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 c57d4826-d94b-4dbe-b164-0a500e34158e 36 fields · synced May 31, 2026