Capio

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name: Capio FDA UDI
Generic Name: Suturing unit, single-use FDA UDI
Device Name: Suture Capturing Device FDA UDI
Model / Reference: M0068312320 FDA UDI
Description: Suture Capturing Device FDA UDI

Identifiers

Primary DI / UDI-DI: 08714729753087 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Suturing unit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Suturing unit, single-use

Capio by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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OverStitch NXT Endoscopic Suturing System — Apollo Endosurgery · Class II
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DISPOSABLE NITINOL NDL SINGLE PACK — Biomet Orthopedics, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Boston Scientific

Sources (1)

FDA UDI 99f88cc5-2314-48fb-9b33-6e188d55ae8f 33 fields · synced May 30, 2026