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AG Spiro Foam Kit

FDA UDI

Class II (US FDA UDI)

by Genadyne Biotechnologies, Inc.

Identity

Trade Name
AG Spiro Foam Kit FDA UDI
Generic Name
Negative-pressure wound therapy system foam dressing, antimicrobial FDA UDI
Device Name
XLR8 PU Foam with AG Kit, Spiro FDA UDI
Model / Reference
XF-SPMK1-AG FDA UDI
Description
XLR8 PU Foam with AG Kit, Spiro FDA UDI

Identifiers

Catalog Number
XF-SPMK1-AG FDA UDI
Primary DI / UDI-DI
00849405000501 FDA UDI
510(k) Number
K082676 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Negative-pressure wound therapy system foam dressing, antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Negative-pressure wound therapy system foam dressing, antimicrobial

AG Spiro Foam Kit by Genadyne Biotechnologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system foam dressing, antimicrobial.

Cleared under the same submission

K082676 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genadyne Biotechnologies, Inc.

Sources (1)

  • FDA UDI c7ec84a6-5564-439a-b68d-bb487cd78582 35 fields · synced Jun 4, 2026