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NSK Sterile Burs/Drills

FDA UDI

Class II (US FDA UDI)

by Nakanishi Inc.

Identity

Trade Name
NSK Sterile Burs/Drills FDA UDI
Generic Name
Orthopaedic bur, single-use FDA UDI
Model / Reference
PDS-1MHD110-30 FDA UDI

Identifiers

Primary DI / UDI-DI
04589551353248 FDA UDI
510(k) Number
K202120 FDA UDI
FDA Product Code
ERL FDA UDI
GFF FDA UDI
EQJ FDA UDI
HBE FDA UDI
GMDN Term
Orthopaedic bur, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4250 FDA UDI
878.4820 FDA UDI
874.4140 FDA UDI
882.4310 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic bur, single-use

NSK Sterile Burs/Drills by Nakanishi Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bur, single-use.

Cleared under the same submission

K202120 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nakanishi Inc.

Sources (1)

  • FDA UDI bf89f410-2ca4-494b-9806-26c597e3ae32 34 fields · synced May 30, 2026