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Vsp Peek

FDA UDI

Class II (US FDA UDI)

by 3d Systems, Inc.

Identity

Trade Name
VSP PEEK FDA UDI
Generic Name
Cranioplasty plate, non-alterable FDA UDI
Device Name
to fill a bony void or defect area in the cranial skeleton of patients FDA UDI
Model / Reference
Cranial Implant FDA UDI
Description
to fill a bony void or defect area in the cranial skeleton of patients FDA UDI

Identifiers

Primary DI / UDI-DI
00816847022675 FDA UDI
510(k) Number
K231834 FDA UDI
FDA Product Code
GWO FDA UDI
GMDN Term
Cranioplasty plate, non-alterable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Cranioplasty plate, non-alterable

Vsp Peek by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranioplasty plate, non-alterable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3d Systems, Inc.

Sources (1)

  • FDA UDI 26dea560-1be1-4802-a60c-4a4f71e78a06 34 fields · synced May 31, 2026