Endovis B.a.

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name: ENDOVIS B.A. FDA UDI
Generic Name: Scalpel handle, reusable FDA UDI
Model / Reference: ø8mmx400mm handle for scalpel FDA UDI

Identifiers

Catalog Number: 4049 FDA UDI
Primary DI / UDI-DI: 08032909625857 FDA UDI
510(k) Number: K113387 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Scalpel handle, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Scalpel handle, reusable

Endovis B.a. by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Anterior Disc Prep — SeaSpine Orthopedics Corporation · Class I
HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
Brasseler USA — Peter Brasseler Holdings, LLC · Class I

Cleared under the same submission

K113387 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Citieffe

Sources (1)

FDA UDI b7c2ffd9-64c7-43ec-9a48-5d9192a72841 36 fields · synced May 30, 2026