Bioseal Inc.

FDA UDI

Class I (US FDA UDI)

by Bioseal

Identity

Trade Name: Bioseal Inc. FDA UDI
Generic Name: Dermatome blade, single-use FDA UDI
Device Name: Sterile Surgical Blades FDA UDI
Model / Reference: 0SU0030 FDA UDI
Description: Sterile Surgical Blades FDA UDI

Identifiers

Primary DI / UDI-DI: 00630094130316 FDA UDI
FDA Product Code: KDC FDA UDI
GMDN Term: Dermatome blade, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dermatome blade, single-use

Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatome blade, single-use.

Integra® Padgett® Dermatomes — Integra Lifesciences Corp. · Class I
Blade for Mucotome — Nouvag AG · Class I
Blade for Dermatome 12mm — Nouvag AG · Class I
Humeca D100 Dermatome blade — Humeca B.V. · Class I
TissueMill — TISSUEMILL TECHNOLOGIES LLC · Class I
Integra® Padgett® Dermatomes — Integra Lifesciences Corp. · Class I
Dermatome — Zimmer Orthopaedic Surgical Products · Class I
Padgett Replacement Dermatome Blades Non-Sterile — ROBBINS INSTRUMENTS · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Bioseal

Sources (1)

FDA UDI b90d72d3-9e1b-4009-b70c-c84c73467d80 33 fields · synced Jun 8, 2026