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Ose

FDA UDI

Class I (US FDA UDI)

by Orthodontic Supply & Equipment Co., Inc.

Identity

Trade Name
OSE FDA UDI
Generic Name
Orthodontic clasp, metal wire, custom-made FDA UDI
Device Name
Lingual Bars - Medium FDA UDI
Model / Reference
0204-020 FDA UDI
Description
Lingual Bars - Medium FDA UDI

Identifiers

Primary DI / UDI-DI
00810042121065 FDA UDI
FDA Product Code
ECN FDA UDI
GMDN Term
Orthodontic clasp, metal wire, custom-made FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5410 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

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthodontic clasp, metal wire, custom-made

Ose by Orthodontic Supply & Equipment Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic clasp, metal wire, custom-made.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthodontic Supply & Equipment Co., Inc.

Sources (1)

  • FDA UDI 75f3be0d-6024-4b86-9778-64f20993de4b 33 fields · synced Jun 1, 2026