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Haki Knife

FDA UDI

Class I (US FDA UDI)

by Bk Meditech Co., Ltd.

Identity

Trade Name
HAKI KNIFE FDA UDI
Generic Name
Orthopaedic knife FDA UDI
Device Name
HAKI Knife FDA UDI
Model / Reference
99102 FDA UDI
Description
HAKI Knife FDA UDI

Identifiers

Primary DI / UDI-DI
08809228120628 FDA UDI
FDA Product Code
GES FDA UDI
GMDN Term
Orthopaedic knife FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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: Orthopaedic knife

Haki Knife by Bk Meditech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic knife.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bk Meditech Co., Ltd.

Sources (1)

  • FDA UDI ea7e5ceb-675f-4610-95ac-9b6ad5e47d4a 33 fields · synced May 30, 2026