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Rawlings

FDA UDI

Class I (US FDA UDI)

by Fgx International Inc.

Identity

Trade Name
RAWLINGS FDA UDI
Generic Name
Tinted non-prescription spectacles FDA UDI
Model / Reference
10237293.QTM FDA UDI

Identifiers

Primary DI / UDI-DI
00887661302991 FDA UDI
FDA Product Code
HQY FDA UDI
GMDN Term
Tinted non-prescription spectacles FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Tinted non-prescription spectacles

Rawlings by Fgx International Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tinted non-prescription spectacles.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI ce143f24-86f9-4c85-8b88-40802dd66d93 33 fields · synced May 30, 2026