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Coulmed

FDA UDI

Class I (US FDA UDI)

by Coulmed Products Group Llc

Identity

Trade Name
Coulmed FDA UDI
Generic Name
Operating table patient pressure distribution pad, reusable FDA UDI
Device Name
Replacement Pads for SKYTRON 3500 Surgical Table. 3 Piece Set; 3" thick. Tier II Pressure Relief Visco Foam with Black Skin-Soft Conductive Covering. FDA UDI
Model / Reference
TSK07-3PR FDA UDI
Description
Replacement Pads for SKYTRON 3500 Surgical Table. 3 Piece Set; 3" thick. Tier II Pressure Relief Visco Foam with Black Skin-Soft Conductive Covering. FDA UDI

Identifiers

Catalog Number
TSK07-3PR FDA UDI
Primary DI / UDI-DI
10810087355163 FDA UDI
FDA Product Code
LWG FDA UDI
GMDN Term
Operating table patient pressure distribution pad, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Operating table patient pressure distribution pad, reusable

Coulmed by Coulmed Products Group Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating table patient pressure distribution pad, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coulmed Products Group Llc

Sources (1)

  • FDA UDI abecb197-936f-458b-b5ff-4c454fb35a19 34 fields · synced Jun 1, 2026