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A53133-75

EUDAMEDFDA UDI

Class III (EU MDR)

Ref A53133-75

by Foosin Medical Supplies Inc., Ltd.

Identity

Trade Name
WEGO-PGCL Absorbable Surgical Suture With Needle FDA UDI
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Model / Reference
A53133-75 EUDAMED
Q63202 FDA UDI

Identifiers

Primary DI / UDI-DI
06941813630852 EUDAMEDFDA UDI
Basic UDI-DI
B-06941813630852 EUDAMED
510(k) Number
K142810 FDA UDI
FDA Product Code
GAM FDA UDI
EMDN Code
H010101020202 POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT WITH NEEDLE FOR VIDEO SURGERY EUDAMED
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
878.4493 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

A53133-75 is a medical device designed for precise suture placement and application, offering a reliable and effective solution for various medical applications. By providing a detailed overview of its features, compliance, and usage guidelines, this device aims to educate users on how to properly utilize it.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

EUDAMED SRN
CN-MF-000006957
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (2)

  • EUDAMED 1538d6e7-37a3-4466-987c-bc1b5b3095d5 61 fields · synced Oct 6, 2026
  • FDA UDI 08be0ef1-8966-4798-88ff-41eec9073dc4 34 fields · synced May 24, 2026