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AceConnex™

FDA UDI

Class II (US FDA UDI)

by Allosource

Identity

Trade Name
AceConnex™ FDA UDI
Generic Name
Cadaveric-donor fascia allograft FDA UDI
Device Name
AceConnex™ Pre-Sutured Fascia FDA UDI
Model / Reference
PSF141060-6 FDA UDI
Description
AceConnex™ Pre-Sutured Fascia FDA UDI

Identifiers

Catalog Number
PSF141060-6 FDA UDI
Primary DI / UDI-DI
00810053078662 FDA UDI
510(k) Number
K213046 FDA UDI
FDA Product Code
GAT FDA UDI
GMDN Term
Cadaveric-donor fascia allograft FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5000 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

Yes

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 60 Millimeter FDA UDI
Outer Diameter — 5.5 Millimeter FDA UDI

Category: Cadaveric-donor fascia allograft

AceConnex™ by Allosource — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cadaveric-donor fascia allograft.

Cleared under the same submission

K213046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Allosource

Sources (1)

  • FDA UDI 9b5e5c91-1429-44fd-b37e-4ffe3aec11b7 37 fields · synced May 30, 2026