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HAART Polyester Pledget 6-Pack

FDA UDI

Class II (US FDA UDI)

by Corcym Inc.

Identity

Trade Name
HAART Polyester Pledget 6-Pack FDA UDI
Generic Name
Cardiovascular patch, synthetic FDA UDI
Device Name
Polyester pledgets for use with HAART Aortic Annuloplasty Devices FDA UDI
Model / Reference
100-06US FDA UDI
Description
Polyester pledgets for use with HAART Aortic Annuloplasty Devices FDA UDI

Identifiers

Catalog Number
100-06US FDA UDI
Primary DI / UDI-DI
10857160006338 FDA UDI
FDA Product Code
DXZ FDA UDI
GMDN Term
Cardiovascular patch, synthetic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3470 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

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
MRI Safety
MR Conditional FDA UDI

Category: Cardiovascular patch, synthetic

HAART Polyester Pledget 6-Pack by Corcym Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular patch, synthetic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corcym Inc.

Sources (1)

  • FDA UDI 7ce50625-c4d2-4ee5-b0f2-0c7d3564fe4a 35 fields · synced May 30, 2026