Signia

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Signia FDA UDI
Generic Name: Surgical staple loading unit, non-cutting FDA UDI
Device Name: Small Diameter Curved Tip Intelligent Reload Vascular/Thin; For use with 8 mm Cannula or larger FDA UDI
Model / Reference: SIGSDS30CTVT FDA UDI
Description: Small Diameter Curved Tip Intelligent Reload Vascular/Thin; For use with 8 mm Cannula or larger FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521741881 FDA UDI
510(k) Number: K191070 FDA UDI
FDA Product Code: GDW FDA UDI
GMDN Term: Surgical staple loading unit, non-cutting FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4750 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

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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 8 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI

Category: Surgical staple loading unit, non-cutting

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

Similar devices

Also classified as Surgical staple loading unit, non-cutting.

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EndoWrist — Intuitive Surgical, Inc. · Class II
arcad® — NOVASTEP · Class II
SureForm — Intuitive Surgical, Inc. · Class II
Endowrist — Intuitive Surgical, Inc. · Class II
ECHELON ENDOPATH — ETHICON ENDO-SURGERY, INC. · Class II

Cleared under the same submission

K191070 also covers:

Signia — Covidien LP
Signia — Covidien LP

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: Covidien LP

Sources (1)

FDA UDI 8598a80e-8cb6-4ddb-9013-291fe013aab3 37 fields · synced Jun 8, 2026