← Back to catalogue

Spectrum, Inc.

FDA UDI

Class I (US FDA UDI)

by Spectrum Co.

Identity

Trade Name
Spectrum, Inc. FDA UDI
Generic Name
Custom-made cushion FDA UDI
Device Name
Sterile Heel/Elbow Flotation Cushion, Large Size FDA UDI
Model / Reference
982-03615-000 FDA UDI
Description
Sterile Heel/Elbow Flotation Cushion, Large Size FDA UDI

Identifiers

Catalog Number
721247 FDA UDI
Primary DI / UDI-DI
00850301007761 FDA UDI
FDA Product Code
KIC FDA UDI
GMDN Term
Custom-made cushion FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3175 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Custom-made cushion

Spectrum, Inc. by Spectrum Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made cushion.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Spectrum Co.

Sources (1)

  • FDA UDI a0a15345-368c-491e-b8a0-1a5de82d275b 35 fields · synced Jun 1, 2026