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: Specimine Container, 16 Oz, Sterile FDA UDI
Model / Reference: 987-03896-000 FDA UDI
Description: Specimine Container, 16 Oz, Sterile FDA UDI

Identifiers

Catalog Number: 725200 FDA UDI
Primary DI / UDI-DI: 00850301007808 FDA UDI
510(k) Number: K863872 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Medical equipment/instrument drape, single-use

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

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Also classified as Medical equipment/instrument drape, single-use.

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MICROTEK — Microtek Medical LLC · Class II
Plasdent — PLASDENT CORP. · Class II
Probe Cover — Advance Medical Designs, Inc. · Class II

Cleared under the same submission

K863872 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 U	Pending data

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Manufacturer

Manufacturer: Spectrum Co.

Sources (1)

FDA UDI e3a92b1d-3bf3-4efa-867f-6aaf7a04861d 36 fields · synced May 30, 2026