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3d

FDA UDI

Class I (US FDA UDI)

by Rmo

Identity

Trade Name
3D FDA UDI
Generic Name
Orthodontic space maintainer FDA UDI
Device Name
3D LINGUAL SECTIONAL U/R L/L FDA UDI
Model / Reference
A04345 FDA UDI
Description
3D LINGUAL SECTIONAL U/R L/L FDA UDI

Identifiers

Primary DI / UDI-DI
00885797085016 FDA UDI
FDA Product Code
DYT FDA UDI
GMDN Term
Orthodontic space maintainer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5525 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic space maintainer

3d by Rmo — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic space maintainer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rmo

Sources (1)

  • FDA UDI 315de3d2-5332-407b-bd8d-9cc625f797f6 33 fields · synced May 30, 2026