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Nordson Medical

FDA UDI

Class II (US FDA UDI)

by Micromedics, Inc.

Identity

Trade Name
Nordson Medical FDA UDI
Generic Name
Fibrin sealant biochemical preparation/application kit, endoscopic FDA UDI
Device Name
Endoscopic Applicator with Mixing Tip, 5mm x 40cm, 1:1 Ratio FDA UDI
Model / Reference
SA-3663 FDA UDI
Description
Endoscopic Applicator with Mixing Tip, 5mm x 40cm, 1:1 Ratio FDA UDI

Identifiers

Primary DI / UDI-DI
00815634021181 FDA UDI
510(k) Number
K042834 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Fibrin sealant biochemical preparation/application kit, endoscopic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Fibrin sealant biochemical preparation/application kit, endoscopic

Nordson Medical by Micromedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fibrin sealant biochemical preparation/application kit, endoscopic.

Cleared under the same submission

K042834 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micromedics, Inc.

Sources (1)

  • FDA UDI 75e35c13-43a8-4349-a2dc-1e69ab3a9810 34 fields · synced May 30, 2026