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Stryker

FDA UDI

Class I (US FDA UDI)

by Provision

Identity

Trade Name
Stryker FDA UDI
Generic Name
Orthopaedic bur, single-use FDA UDI
Model / Reference
5820-12-050 FDA UDI

Identifiers

Primary DI / UDI-DI
B504OM5820120500 FDA UDI
FDA Product Code
GFF FDA UDI
GMDN Term
Orthopaedic bur, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic bur, single-use

Stryker Orthopaedic Bur, a high-quality, single-use surgical device designed for precise bone excavation and shaping during orthopaedic procedures. This rotary cutting device is engineered to fit comfortably in the handpiece, allowing users to achieve excellent results with minimal effort.

Similar devices

Also classified as Orthopaedic bur, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Provision

Sources (1)

  • FDA UDI 3b9df7a3-5580-410e-92b5-f791004c5fbc 32 fields · synced Jul 15, 2026