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Onflex

FDA UDI

Class II (US FDA UDI)

by Davol Inc.

Identity

Trade Name
ONFLEX FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Device Name
Modified OnFlex Mesh, 4.0" x 6.2" (10.2 cm x 15.7 cm), Large FDA UDI
Model / Reference
0115611 FDA UDI
Description
Modified OnFlex Mesh, 4.0" x 6.2" (10.2 cm x 15.7 cm), Large FDA UDI

Identifiers

Catalog Number
0115611 FDA UDI
Primary DI / UDI-DI
00801741095405 FDA UDI
FDA Product Code
FTL FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 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

Dimensions & Sizes

Size
Length — 10.2 Centimeter FDA UDI
Width — 15.7 Centimeter FDA UDI

Category: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Onflex by Davol Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Davol Inc.

Sources (1)

  • FDA UDI c4b95cb1-20a0-4f75-abc7-cb1139696347 36 fields · synced Jun 6, 2026