Sigma

FDA UDI

Class I (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: SIGMA FDA UDI
Generic Name: Orthopaedic instrument surgical connector FDA UDI
Device Name: SIGMA HP REVISION INSTRUMENTS FEMORAL ADAPTOR SLEEVE BOLT TRIAL FDA UDI
Model / Reference: 2011-03-052 FDA UDI
Description: SIGMA HP REVISION INSTRUMENTS FEMORAL ADAPTOR SLEEVE BOLT TRIAL FDA UDI

Identifiers

Catalog Number: 201103052 FDA UDI
Primary DI / UDI-DI: 10603295081715 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Orthopaedic instrument surgical connector FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic instrument surgical connector

Sigma by Depuy (ireland) — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
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MIS Curved Rod, Ø5.5 x 85mm — Captiva Spine · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Depuy (ireland)

Sources (1)

FDA UDI 70f29fea-ff00-4cf3-9bdc-e6763e063208 35 fields · synced Jun 1, 2026