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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
Abdominal/intestinal spatula FDA UDI
Device Name
Olivecrona spatula, 7'', double-ended, convex, 16.0mm x 18.0mm wide blades, flat handle FDA UDI
Model / Reference
Olivecrona spatula FDA UDI
Description
Olivecrona spatula, 7'', double-ended, convex, 16.0mm x 18.0mm wide blades, flat handle FDA UDI

Identifiers

Catalog Number
45-457 FDA UDI
Primary DI / UDI-DI
00190660175795 FDA UDI
FDA Product Code
HAO FDA UDI
GMDN Term
Abdominal/intestinal spatula FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4535 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: Abdominal/intestinal spatula

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

Similar devices

Also classified as Abdominal/intestinal spatula.

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 2e431616-8f30-467c-9452-ba7ba64c36e5 35 fields · synced Jun 6, 2026