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SurgiMesh

FDA UDI

Class II (US FDA UDI)

by Bg Medical, Llc

Identity

Trade Name
SurgiMesh FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Model / Reference
T1415 FDA UDI

Identifiers

Primary DI / UDI-DI
00850011929155 FDA UDI
510(k) Number
K061445 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

No

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

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

SurgiMesh by Bg Medical, Llc — 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.

Cleared under the same submission

K061445 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bg Medical, Llc

Sources (1)

  • FDA UDI 039e8b15-03bb-40ef-8f28-5d68cbda5201 33 fields · synced May 30, 2026