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G&H Safety Release Module, 450 Gr

FDA UDI

Class II (US FDA UDI)

by G&H Wire Company, Inc.

Identity

Trade Name
G&H SAFETY RELEASE MODULE, 450 GR FDA UDI
Generic Name
Orthodontic extraoral headgear FDA UDI
Device Name
Our Safety Release Modules are available in 3 force ranges to provide dependable retraction. The specially designed retention clip releases at 4 to 5 lbs. of outward force for patient safety. FDA UDI
Model / Reference
SR**450 FDA UDI
Description
Our Safety Release Modules are available in 3 force ranges to provide dependable retraction. The specially designed retention clip releases at 4 to 5 lbs. of outward force for patient safety. FDA UDI

Identifiers

Primary DI / UDI-DI
10190886000472 FDA UDI
FDA Product Code
DZB FDA UDI
GMDN Term
Orthodontic extraoral headgear FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5500 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

Category: Orthodontic extraoral headgear

G&H Safety Release Module, 450 Gr by G&H Wire Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic extraoral headgear.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
G&H Wire Company, Inc.

Sources (1)

  • FDA UDI 8652bc15-33b1-4ec7-bcf0-9cb50ddeeb11 34 fields · synced Jun 8, 2026