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Invivo

FDA UDI

Class II (US FDA UDI)

by Philips DS North America LLC

Identity

Trade Name
Invivo FDA UDI
Generic Name
Soft-tissue biopsy procedure kit, non-medicated FDA UDI
Device Name
3T Semi Automatic Biopsy Set FDA UDI
Model / Reference
98960320412 FDA UDI
Description
3T Semi Automatic Biopsy Set FDA UDI

Identifiers

Primary DI / UDI-DI
00884838072626 FDA UDI
FDA Product Code
KNW FDA UDI
GMDN Term
Soft-tissue biopsy procedure kit, non-medicated 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 12 Gauge FDA UDI
Needle Gauge — 14 Gauge FDA UDI
Length — 150 Millimeter FDA UDI

Category: Soft-tissue biopsy procedure kit, non-medicated

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

Similar devices

Also classified as Soft-tissue biopsy procedure kit, non-medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips DS North America LLC

Sources (1)

  • FDA UDI 7622875d-04f3-458d-870e-f66239522057 36 fields · synced Jun 8, 2026