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Kitsune

FDA UDI

Class I (US FDA UDI)

by Medshape, Inc.

Identity

Trade Name
Kitsune FDA UDI
Generic Name
Fluted surgical drill bit, single-use, non-sterile FDA UDI
Device Name
1.5mm Staple Drill, Reusable, Kitsune FDA UDI
Model / Reference
2800-03-015 FDA UDI
Description
1.5mm Staple Drill, Reusable, Kitsune FDA UDI

Identifiers

Primary DI / UDI-DI
M9702800030150 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
Fluted surgical drill bit, single-use, non-sterile FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Fluted surgical drill bit, single-use, non-sterile

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

Similar devices

Also classified as Fluted surgical drill bit, single-use, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medshape, Inc.

Sources (1)

  • FDA UDI 04d84ce0-057a-412c-aeb0-2ecc5c982d2d 33 fields · synced May 31, 2026