Preventive Pad PPWD381645

GUDID 10810006683629

Preventive Pad - (38" x 16" x 4.5") - Wipe Down

PRIMO INC

Freestanding patient positioner, single-use
Primary Device ID10810006683629
NIH Device Record Key709276dd-6e42-433b-9821-e09cb7efda54
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreventive Pad
Version Model NumberPPWD381645
Catalog NumberPPWD381645
Company DUNS958758146
Company NamePRIMO 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810006683622 [Primary]
GS110810006683629 [Package]
Contains: 00810006683622
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

FMPProtector, Skin Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-30
Device Publish Date2021-07-22

On-Brand Devices [Preventive Pad]

00810006683301Preventive Pad - Short (28" x 14" x 4.5") - Wipe Down
00810006683295Preventive Pad - Short (28" x 14" x 4.5") - Sheepskin
00810006683288Preventive Pad - Short (28" x 14" x 4.5")
00810006680973Preventive Pad - Standard (28" x 16" x 4.5") - Wipe Down
00810006680966Preventive Pad - Standard (28" x 16" x 4.5")
10810006683643Preventive Pad - (38" x 14" x 4.5") - Wipe Down
10810006683629Preventive Pad - (38" x 16" x 4.5") - Wipe Down
00810006683318Preventive Pad - (28" x 16" x 4.5") - Wipe Down

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.