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Megasorb

FDA UDI

Class II (US FDA UDI)

by Meril Endo Surgery Private Limited

Identity

Trade Name
MEGASORB FDA UDI
Generic Name
Skin-closing tension device FDA UDI
Device Name
Braided coated Polyglycolic Acid Surgical Suture USP FDA UDI
Model / Reference
MS011428 FDA UDI
Description
Braided coated Polyglycolic Acid Surgical Suture USP FDA UDI

Identifiers

Catalog Number
MS011428 FDA UDI
Primary DI / UDI-DI
08904255202658 FDA UDI
510(k) Number
K172659 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Skin-closing tension device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 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
MRI Safety
MR Safe FDA UDI

Category: Skin-closing tension device

Megasorb by Meril Endo Surgery Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin-closing tension device.

Cleared under the same submission

K172659 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meril Endo Surgery Private Limited

Sources (1)

  • FDA UDI a86437dc-17ff-4dcd-8601-a6a9960b54fb 37 fields · synced May 31, 2026