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3.5 Cortex Screw, hex, tapping, TI, L 44mm

FDA UDI

Class II (US FDA UDI)

by mahe medical gmbh

Identity

Trade Name
3.5 Cortex Screw, hex, tapping, TI, L 44mm FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
3.5 Cortex Screw, hex, tapping, TI, L 44mm FDA UDI
Model / Reference
001-0004-044ST FDA UDI
Description
3.5 Cortex Screw, hex, tapping, TI, L 44mm FDA UDI

Identifiers

Catalog Number
001-0004-044ST FDA UDI
Primary DI / UDI-DI
EMAH0010004044ST0 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 44.0 Millimeter FDA UDI
Outer Diameter — 3.5 Millimeter FDA UDI

Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile

3.5 Cortex Screw, hex, tapping, TI, L 44mm by mahe medical gmbh — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
mahe medical gmbh

Sources (1)

  • FDA UDI 7d71a0a0-d0c9-445e-9423-b46e5923cb29 36 fields · synced Jun 6, 2026