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Spectrum, Inc.

FDA UDI

Class U (US FDA UDI)

by Spectrum Co.

Identity

Trade Name
Spectrum, Inc. FDA UDI
Generic Name
Medical equipment/instrument drape, single-use FDA UDI
Device Name
Sterile Equipment Drape, 12" X 100" w/Bag Clip, Latex Free FDA UDI
Model / Reference
982-03954-001 FDA UDI
Description
Sterile Equipment Drape, 12" X 100" w/Bag Clip, Latex Free FDA UDI

Identifiers

Catalog Number
SD-100 FDA UDI
Primary DI / UDI-DI
00855495007351 FDA UDI
510(k) Number
K934630 FDA UDI
FDA Product Code
LPZ FDA UDI
GMDN Term
Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Safe FDA UDI

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

Cleared under the same submission

K934630 also covers:

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 2101c9fe-7716-4d9c-9b98-51980589b7e5 37 fields · synced Jun 1, 2026