8mm x 8mm Staple System

FDA UDI

Class II (US FDA UDI)

by Trilliant Surgical LLC

Identity

Trade Name: 8mm x 8mm Staple System FDA UDI
Generic Name: Surgical staple loading unit, non-cutting FDA UDI
Device Name: 8mm Sniper Sterile Staple Kit FDA UDI
Model / Reference: 500-08-001 FDA UDI
Description: 8mm Sniper Sterile Staple Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 00812926027500 FDA UDI
510(k) Number: K162354 FDA UDI
FDA Product Code: JDR FDA UDI
GMDN Term: Surgical staple loading unit, non-cutting FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 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

Yes

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

Dimensions & Sizes

Size: Width — 8 Millimeter FDA UDI
Height — 8 Millimeter FDA UDI

Category: Surgical staple loading unit, non-cutting

8mm x 8mm Staple System by Trilliant Surgical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Endowrist — Intuitive Surgical, Inc. · Class II
SureForm — Intuitive Surgical, Inc. · Class II
EndoWrist — Intuitive Surgical, Inc. · Class II
GIA — Covidien LP · Class II
EndoWrist — Intuitive Surgical, Inc. · Class II
arcad® — NOVASTEP · Class II
SureForm — Intuitive Surgical, Inc. · Class II
Tri-Staple 2.0 — Covidien LP · Class II

Cleared under the same submission

K162354 also covers:

10mm x 10mm Staple System — Trilliant Surgical LLC

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: Trilliant Surgical LLC

Sources (1)

FDA UDI bd0c381a-af98-43cd-83f4-aaf989329279 35 fields · synced May 30, 2026