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Spectrum, Inc.

FDA UDI

Class II (US FDA UDI)

by Spectrum Co.

Identity

Trade Name
Spectrum, Inc. FDA UDI
Generic Name
Syringe filter, clinical FDA UDI
Device Name
Hydrophilic Syringe Tip Filter - DG2M-110-50S, Sterile FDA UDI
Model / Reference
DG2M-230 FDA UDI
Description
Hydrophilic Syringe Tip Filter - DG2M-110-50S, Sterile FDA UDI

Identifiers

Catalog Number
DG2M-110-50S FDA UDI
Primary DI / UDI-DI
00850301007587 FDA UDI
510(k) Number
K852996 FDA UDI
FDA Product Code
FPB FDA UDI
GMDN Term
Syringe filter, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Commercial Distribution
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
Radiation Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Syringe filter, clinical

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

Similar devices

Also classified as Syringe filter, clinical.

Cleared under the same submission

K852996 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectrum Co.

Sources (1)

  • FDA UDI ea0943a6-62f0-4fe0-be09-11cbb3348b54 36 fields · synced May 30, 2026