SurgyPad

GUDID 00810014630038

U.S. SURGITECH INC.

Trendelenburg positioning pad
Primary Device ID00810014630038
NIH Device Record Key1350484e-02bc-4c0a-8d4f-d464aeaa0cd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgyPad
Version Model Number780-421
Company DUNS142007082
Company NameU.S. SURGITECH INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810014630021 [Primary]
GS100810014630038 [Package]
Contains: 00810014630021
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

CCXSupport, Patient Position

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-04
Device Publish Date2019-11-26

On-Brand Devices [SurgyPad]

00810014630038780-421
00810014630014780-420
00810014636832SurgyPad with Integrated Adjustable Arms Protectors 36"

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