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Bioplate®

FDA UDI

Class I (US FDA UDI)

by Bioplate, Inc.

Identity

Trade Name
Bioplate® FDA UDI
Generic Name
Orthopaedic implantable-device cutter FDA UDI
Device Name
Maxfax Set Basic FDA UDI
Model / Reference
K248-50 FDA UDI
Description
Maxfax Set Basic FDA UDI

Identifiers

Catalog Number
K248-50 FDA UDI
Primary DI / UDI-DI
M384K248500 FDA UDI
FDA Product Code
DZA FDA UDI
HTD FDA UDI
FZT FDA UDI
LRZ FDA UDI
FSM FDA UDI
HAO FDA UDI
GMDN Term
Orthopaedic implantable-device cutter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4130 FDA UDI
878.4800 FDA UDI
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

Yes

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: Instrument tray, reusableSurgical screwdriver, reusableDressing/utility forceps, tweezers-like, reusableFluted surgical drill bit, single-use

Bioplate® by Bioplate, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implantable-device cutter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioplate, Inc.

Sources (1)

  • FDA UDI 400ec30b-0f42-4824-acc6-e725d2336025 34 fields · synced May 30, 2026