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Auto Suture

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Auto Suture FDA UDI
Generic Name
Laparoscopic multi-instrument access port, single-use FDA UDI
Device Name
Blunt Tip Trocar FDA UDI
Model / Reference
OMS-T10BT FDA UDI
Description
Blunt Tip Trocar FDA UDI

Identifiers

Primary DI / UDI-DI
10884521080874 FDA UDI
510(k) Number
K924011 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Laparoscopic multi-instrument access port, 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

No

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

Dimensions & Sizes

Size
Outer Diameter — 10 Millimeter FDA UDI

Category: Laparoscopic multi-instrument access port, single-use

Auto Suture by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic multi-instrument access port, single-use.

Cleared under the same submission

K924011 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI a4f37d86-f34a-4fb8-9c40-26652bb56a59 37 fields · synced Jun 8, 2026