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Phasix

FDA UDI

Class II (US FDA UDI)

by Davol Inc.

Identity

Trade Name
Phasix FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
Device Name
Phasix ST Mesh with Echo 2 Positioning System, 10 cm x 15 cm (4" x 6"), Ellipse FDA UDI
Model / Reference
1211015 FDA UDI
Description
Phasix ST Mesh with Echo 2 Positioning System, 10 cm x 15 cm (4" x 6"), Ellipse FDA UDI

Identifiers

Catalog Number
1211015 FDA UDI
Primary DI / UDI-DI
00801741161247 FDA UDI
FDA Product Code
GCJ FDA UDI
OWT FDA UDI
ORQ FDA UDI
OOD FDA UDI
FTL FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
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 Centimeter FDA UDI
Width — 15 Centimeter FDA UDI

Category: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableSurgical mesh laparoscopic delivery/positioning device

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

Similar devices

Also classified as Surgical mesh laparoscopic delivery/positioning device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Davol Inc.

Sources (1)

  • FDA UDI 1b643976-3b43-46e3-b02f-38869be3b921 37 fields · synced Jun 7, 2026