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Phasix

FDA UDI

Class II (US FDA UDI)

by Davol Inc.

Identity

Trade Name
Phasix FDA UDI
Generic Name
Surgical mesh laparoscopic delivery/positioning device FDA UDI
Device Name
Phasix ST Mesh with Echo 2 Positioning System, 15 cm x 20 cm (6" x 8"), Ellipse FDA UDI
Model / Reference
1211520 FDA UDI
Description
Phasix ST Mesh with Echo 2 Positioning System, 15 cm x 20 cm (6" x 8"), Ellipse FDA UDI

Identifiers

Catalog Number
1211520 FDA UDI
Primary DI / UDI-DI
00801741161254 FDA UDI
FDA Product Code
FTL FDA UDI
OOD FDA UDI
ORQ FDA UDI
OWT FDA UDI
GCJ FDA UDI
GMDN Term
Surgical mesh laparoscopic delivery/positioning device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
876.1500 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

No

FDA UDI

Dimensions & Sizes

Size
Length — 15 Centimeter FDA UDI
Width — 20 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 38b7ba8a-659e-4218-81f4-55b76be7e36b 37 fields · synced Jun 8, 2026