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AngioSystems Drape

FDA UDI

Class II (US FDA UDI)

by Angiosystems, Incorporated

Identity

Trade Name
AngioSystems Drape FDA UDI
Generic Name
Patient surgical drape, single-use FDA UDI
Model / Reference
3028 FDA UDI

Identifiers

Primary DI / UDI-DI
00816611020104 FDA UDI
510(k) Number
K843260 FDA UDI
FDA Product Code
KKX FDA UDI
GMDN Term
Patient surgical drape, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

No

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: Patient surgical drape, single-use

AngioSystems Drape by Angiosystems, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient surgical drape, single-use.

Cleared under the same submission

K843260 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Angiosystems, Incorporated

Sources (1)

  • FDA UDI 355c0b7c-9c2b-4f3d-b8a6-ff9ec8d365df 33 fields · synced Jun 1, 2026