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Glide

FDA UDI

Class I (US FDA UDI)

by Infinite Biomedical Technologies LLC

Identity

Trade Name
Glide FDA UDI
Generic Name
Analytical non-scalp cutaneous electrode FDA UDI
Device Name
Core2 Fabrication Kit FDA UDI
Model / Reference
94001 FDA UDI
Description
Core2 Fabrication Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00850004850756 FDA UDI
510(k) Number
K240884 FDA UDI
FDA Product Code
IQZ FDA UDI
GXY FDA UDI
GMDN Term
Analytical non-scalp cutaneous electrode FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3420 FDA UDI
882.1320 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

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

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Analytical non-scalp cutaneous electrodeMyoelectric hand prosthesis

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

Similar devices

Also classified as Myoelectric hand prosthesis.

Cleared under the same submission

K240884 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Infinite Biomedical Technologies LLC

Sources (1)

  • FDA UDI 9d0659e8-e59b-484b-b8cb-7778d1f4c217 34 fields · synced Jun 8, 2026