Invivo

FDA UDI

Class II (US FDA UDI)

by Philips DS North America LLC

Identity

Trade Name: Invivo FDA UDI
Generic Name: Manual surgical rotary handpiece, reusable FDA UDI
Device Name: Handle FDA UDI
Model / Reference: 98960320375 FDA UDI
Description: Handle FDA UDI

Identifiers

Primary DI / UDI-DI: 00884838073265 FDA UDI
510(k) Number: K981320 FDA UDI
FDA Product Code: KNW FDA UDI
GMDN Term: Manual surgical rotary handpiece, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1075 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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

MRI Safety

MR Conditional FDA UDI

Category: Manual surgical rotary handpiece, reusable

Invivo by Philips DS North America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Ambler Surgical — Ambler Surgical, LLC · Class I
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Cleared under the same submission

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 II	Pending data

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Manufacturer

Manufacturer: Philips DS North America LLC

Sources (1)

FDA UDI 922a9116-49be-4f24-ab75-3ed098aa40e7 36 fields · synced Jun 8, 2026