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Spetzler - OMT

FDA UDI

Class II (US FDA UDI)

by Omt, Llc

Identity

Trade Name
Spetzler - OMT FDA UDI
Generic Name
Cottonoid pad FDA UDI
Device Name
Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use. FDA UDI
Model / Reference
Neuro Patties FDA UDI
Description
Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use. FDA UDI

Identifiers

Catalog Number
ALL FDA UDI
Primary DI / UDI-DI
M731100020 FDA UDI
510(k) Number
K020736 FDA UDI
FDA Product Code
HBA FDA UDI
GMDN Term
Cottonoid pad FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4700 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

No

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

Yes

FDA UDI

Category: Cottonoid pad

Spetzler - OMT by Omt, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cottonoid pad.

Cleared under the same submission

K020736 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Omt, Llc

Sources (1)

  • FDA UDI 1a46fd0a-f258-4dbc-97e5-3fd6dc993291 37 fields · synced Jun 8, 2026