Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Surgical drill guide obturator FDA UDI
Device Name: ArthFlow® obturator, 5.50mm diameter, blunt, blue color code FDA UDI
Model / Reference: ArthFlow® obturator FDA UDI
Description: ArthFlow® obturator, 5.50mm diameter, blunt, blue color code FDA UDI

Identifiers

Catalog Number: 96-285 FDA UDI
Primary DI / UDI-DI: 00190660196219 FDA UDI
FDA Product Code: FBM FDA UDI
GMDN Term: Surgical drill guide obturator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5090 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide obturator

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ambler Surgical, LLC

Sources (1)

FDA UDI 67dd4a73-39bf-4995-ba11-21a1e25d175e 35 fields · synced Jun 6, 2026