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3dmax

FDA UDI

Class II (US FDA UDI)

by Davol Inc.

Identity

Trade Name
3DMAX FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Device Name
3DMax Mesh, 8.5 cm x 13.7 cm (3.3" x 5.4"), Right, Medium FDA UDI
Model / Reference
0115320 FDA UDI
Description
3DMax Mesh, 8.5 cm x 13.7 cm (3.3" x 5.4"), Right, Medium FDA UDI

Identifiers

Catalog Number
0115320 FDA UDI
Primary DI / UDI-DI
00801741030758 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

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 8.5 Centimeter FDA UDI
Length — 13.7 Centimeter FDA UDI

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

3dmax 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 084e0b5a-2f1b-4b95-913c-4fa254152762 36 fields · synced May 30, 2026