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Drape KB100 Series

FDA UDI

Class II (US FDA UDI)

by Kent Imaging Inc

Identity

Trade Name
Drape KB100 Series FDA UDI
Generic Name
Patient surgical drape, single-use FDA UDI
Device Name
Drapes designed to limit light exposure from the environment, to be used in combination with device SnapshotGLO Model KB100, individually packaged for one-time use only. FDA UDI
Model / Reference
KB100D FDA UDI
Description
Drapes designed to limit light exposure from the environment, to be used in combination with device SnapshotGLO Model KB100, individually packaged for one-time use only. FDA UDI

Identifiers

Primary DI / UDI-DI
B376KB100D0 FDA UDI
FDA Product Code
PUI FDA UDI
GMDN Term
Patient surgical drape, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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: Patient surgical drape, single-use

Drape KB100 Series by Kent Imaging Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient surgical drape, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kent Imaging Inc

Sources (1)

  • FDA UDI 3aac06f1-2838-4748-98a8-d6636697e863 33 fields · synced Jun 8, 2026