Stoma®

FDA UDI

Class II (US FDA UDI)

by Storz am Mark GmbH

Identity

Trade Name: STOMA® FDA UDI
Generic Name: Craniofacial bone screw, non-bioabsorbable FDA UDI
Device Name: Titanium-screw, cross-slot, Ø 1,3mm,14mm, yellow, 3 pcs FDA UDI
Model / Reference: 23053.14 FDA UDI
Description: Titanium-screw, cross-slot, Ø 1,3mm,14mm, yellow, 3 pcs FDA UDI

Identifiers

Catalog Number: 23053.14 FDA UDI
Primary DI / UDI-DI: ESAM23053141 FDA UDI
FDA Product Code: DZL FDA UDI
GMDN Term: Craniofacial bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

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: Craniofacial bone screw, non-bioabsorbable

Stoma® by Storz am Mark GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Craniofacial bone screw, non-bioabsorbable.

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MatrixMANDIBLE — Synthes · Class II
OsteoMed — Osteomed Corp. · Class II
LEVEL ONE NEURO, STERILE — KLS-Martin L.P. · Class II
Leforte System Bone Screw / GBR System Bone Screw — Jeil Medical Corporation · 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 II	Pending data

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Manufacturer

Manufacturer: Storz am Mark GmbH

Sources (1)

FDA UDI b03d9ae9-0ca7-43dc-9e2a-a0b4d172d3cc 35 fields · synced Jun 1, 2026