Positioning Wedges 30-207-00

GUDID 00810044960297

45 Degree Positioning Wedge 18" X 7.5" X 7.5"

GENEVA HEALTHCARE, LLC

Freestanding patient positioner, single-use
Primary Device ID00810044960297
NIH Device Record Key2679678f-3b5e-48ae-a4ca-8f54ee716535
Commercial Distribution StatusIn Commercial Distribution
Brand NamePositioning Wedges
Version Model Number30-207-00
Catalog Number30-207-00
Company DUNS964459106
Company NameGENEVA HEALTHCARE, LLC
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810044960297 [Package]
Contains: 10810044960294
Package: Case [8 Units]
In Commercial Distribution
GS110810044960294 [Primary]

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 Date2020-03-03
Device Publish Date2020-02-24

On-Brand Devices [Positioning Wedges]

10850013699398Body Aligner Wedge 21" X 11.5" x 8">2"
1085001369938145 Degree Positioning Wedge 23" X 11" X 11"
1085001369937445 Degree Positioning Wedge 24" X 24" X 12.5"
1085001369930530 Degree / 60 Degree Positioning Wedge 21" X 11" X 8"
1085001369929945 Degree Positioning Wedge 18" X 7.5" X 7.5"
00810044960396Body Aligner Wedge 21" X 11.5" x 8">2"
0081004496038945 Degree Positioning Wedge 23" X 11" X 11"
0081004496037245 Degree Positioning Wedge 24" X 24" X 12.5"
0081004496030330 Degree / 60 Degree Positioning Wedge 21" X 11" X 8"
0081004496029745 Degree Positioning Wedge 18" X 7.5" X 7.5"
0081004496054945 Degree Positioning Wedge, Pediatric 12" X 7.5" X 3.5"

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.