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OsteoMed

FDA UDI

Class II (US FDA UDI)

by Osteomed Corp.

Identity

Trade Name
OsteoMed FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Device Name
2.4mm x 14mm Cannulated Lag Screw FDA UDI
Model / Reference
319-2414 FDA UDI
Description
2.4mm x 14mm Cannulated Lag Screw FDA UDI

Identifiers

Catalog Number
319-2414 FDA UDI
Primary DI / UDI-DI
00845694009690 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 14 Millimeter FDA UDI

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

OsteoMed by Osteomed Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osteomed Corp.

Sources (1)

  • FDA UDI 238828d8-d685-4c3c-9895-1d0f0331e475 36 fields · synced May 31, 2026