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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
Upper-limb traction wrap/trap, reusable FDA UDI
Device Name
Ross aortic valve retractor, 10'', size #1, 5/8'' x 5/8'' blade, hexagonal handle FDA UDI
Model / Reference
Ross aortic valve retractor FDA UDI
Description
Ross aortic valve retractor, 10'', size #1, 5/8'' x 5/8'' blade, hexagonal handle FDA UDI

Identifiers

Catalog Number
72-971 FDA UDI
Primary DI / UDI-DI
00190660141448 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Upper-limb traction wrap/trap, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4500 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: Upper-limb traction wrap/trap, reusable

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

Similar devices

Also classified as Upper-limb traction wrap/trap, reusable.

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 faaba20b-4210-42a8-92af-f6a5d57bf108 35 fields · synced May 31, 2026