Dermaclose

FDA UDI

Class I (US FDA UDI)

by Synovis Micro Companies Alliance, Inc

Identity

Trade Name: DERMACLOSE FDA UDI
Generic Name: Skin-closing tension device FDA UDI
Device Name: DERMACLOSE (95CM) US-APAC FDA UDI
Model / Reference: 580122000011 FDA UDI
Description: DERMACLOSE (95CM) US-APAC FDA UDI

Identifiers

Catalog Number: GEM204020 FDA UDI
Primary DI / UDI-DI: 00844735006735 FDA UDI
FDA Product Code: MKY FDA UDI
GMDN Term: Skin-closing tension device FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Skin-closing tension device

Dermaclose by Synovis Micro Companies Alliance, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MEGASORB — MERIL ENDO SURGERY PRIVATE LIMITED · Class II
MEGASORB — MERIL ENDO SURGERY PRIVATE LIMITED · Class II

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: Synovis Micro Companies Alliance, Inc

Sources (1)

FDA UDI f33aea93-4dae-4f31-b0e9-07ab494e0674 35 fields · synced May 30, 2026