Glide

FDA UDI

Class II (US FDA UDI)

by Infinite Biomedical Technologies LLC

Identity

Trade Name: Glide FDA UDI
Generic Name: Myoelectric hand prosthesis FDA UDI
Device Name: Glide FDA UDI
Model / Reference: 91000-GL-B FDA UDI
Description: Glide FDA UDI

Identifiers

Primary DI / UDI-DI: 00850004850626 FDA UDI
510(k) Number: K240884 FDA UDI
FDA Product Code: GXY FDA UDI
IQZ FDA UDI
GMDN Term: Myoelectric hand prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1320 FDA UDI
890.3420 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Glide by Infinite Biomedical Technologies LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K240884 also covers:

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: Infinite Biomedical Technologies LLC

Sources (1)

FDA UDI acd0e684-a549-4c5a-8c55-c0fdb816e0ba 35 fields · synced May 31, 2026