ProneView D28706

GUDID 00850017419193

MOLDED HIP AND THIGH ACCESSORY PACK

DUPACO, INC.

Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use
Primary Device ID00850017419193
NIH Device Record Key39dc6b2f-18f2-4cd1-b054-ed002fc6f064
Commercial Distribution StatusIn Commercial Distribution
Brand NameProneView
Version Model NumberD28706
Catalog NumberD28706
Company DUNS093616555
Company NameDUPACO, INC.
Device Count5
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850017419193 [Unit of Use]
GS100850017419193 [Unit of Use]
GS100850017419193 [Unit of Use]
GS100850017419193 [Unit of Use]
GS100850017419193 [Unit of Use]
GS100850017419193 [Unit of Use]
GS100850017419193 [Unit of Use]
GS100850017419193 [Unit of Use]
GS110850017419190 [Primary]
GS110850017419190 [Primary]
GS110850017419190 [Primary]
GS110850017419190 [Primary]
GS110850017419190 [Primary]
GS110850017419190 [Primary]
GS110850017419190 [Primary]
GS110850017419190 [Primary]

FDA Product Code

CCXSUPPORT, PATIENT POSITION
CCXSUPPORT, PATIENT POSITION
CCXSUPPORT, PATIENT POSITION
CCXSUPPORT, PATIENT POSITION
CCXSUPPORT, PATIENT POSITION
CCXSUPPORT, PATIENT POSITION
CCXSUPPORT, PATIENT POSITION
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 Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [ProneView]

00850017419124LARGE CUSHION 60 PACK
00850017419315PRONECAM 6 PACK
10850017419305FASTENING ROD ASSEMBLY
10850017419275PRONEVIEW TABLE PLATFORM
10850017419268PRONEVIEW ADJUSTABLE MIRROR, DE Pack
10850017419251PRONEVIEW ADJUSTABLE MIRROR Pack
10850017419244PRONEVIEW MIRROR PLATFORM WITH POST HOLES Pack
10850017419237PRONEVIEW MIRROR PLATFORM, DE Pack
10850017419220PRONEVIEW MIRROR PLATFORM Pack
10850017419213PRONEVIEW ADJUSTABLE PROTECTIVE HELMET Pack
10850017419206PRONEVIEW PROTECTIVE HELMET Pack
00850017419193MOLDED HIP AND THIGH ACCESSORY PACK
00850017419186CHEST CUSHION SET
00850017419179CHEST ROLL SET
00850017419162ARM CUSHION SET
00850017419155PRONEVIEW MOLDED SPINAL TABLE POSITIONING PACK
00850017419148PRONEVIEW SURIGICAL FRAME POSITIONING PACK
00850017419131PRONEVIEW SPINAL POSITIONING PACK
00850017419117MEDIUM CUSHION 10 PACK
00850017419100SMALL CUSHION 10 PACK
00850017419353PRONEVIEW ADJUSTABLE PROTECTIVE HELMET AND MIRROR SYS Kit
00850017419346PRONEVIEW TABLE PLATFORMWITH PROTECTIVE HELMET Kit

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