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Mitsu

FDA UDI

Class II (US FDA UDI)

by Meril Endo Surgery Private Limited

Identity

Trade Name
MITSU FDA UDI
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Device Name
Braided coated Poly (glycolide / l–lactide) Surgical Suture FDA UDI
Model / Reference
PGN30416UZ FDA UDI
Description
Braided coated Poly (glycolide / l–lactide) Surgical Suture FDA UDI

Identifiers

Catalog Number
PGN30416UZ FDA UDI
Primary DI / UDI-DI
18904255203324 FDA UDI
510(k) Number
K172659 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial 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: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

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

Similar devices

Also classified as Polyester suture, bioabsorbable, multifilament, non-antimicrobial.

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 900e3d5c-7430-409c-9c6c-4cb0b7545aa2 37 fields · synced Jun 1, 2026