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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 ribbon retractor, malleable, 3" x 6" blade FDA UDI
Model / Reference
70-710 FDA UDI
Description
Bookwalter ribbon retractor, malleable, 3" x 6" blade FDA UDI

Identifiers

Catalog Number
70-710 FDA UDI
Primary DI / UDI-DI
00190660132408 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

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Manufacturer

Manufacturer
Ambler Surgical, LLC

Sources (1)

  • FDA UDI 38494628-db1d-4c9a-9e09-bb31b93faea1 36 fields · synced Jun 1, 2026