Arjo Wiggins Medical, Inc. 1010884040D

GUDID 00815588024443

88 40X40,100_CASE

STERIMED INC.

Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use
Primary Device ID00815588024443
NIH Device Record Key56b7b48f-68cb-40b4-b4f2-c40514a8b099
Commercial Distribution StatusIn Commercial Distribution
Brand NameArjo Wiggins Medical, Inc.
Version Model Number1010884040D
Catalog Number1010884040D
Company DUNS182052670
Company NameSTERIMED INC.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
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(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com
Phone+1(843)388-8080
Emailmpendergraph@arjomedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100815588024443 [Primary]
GS100815588024856 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRGWrap, sterilization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2016-09-21

On-Brand Devices [Arjo Wiggins Medical, Inc.]

0081558802477188 54X72,50_CASE YB
0081558802476488 54X72,50_CASE Y
0081558802475788 54X54,100_CASE YB
0081558802473388 54X54,100_CASE Y
0081558802471988 54X54,100_CASE
0081558802469688 54X54,1600/CS-GAYLORD
0081558802467288 54X54,100_CASE
0081558802465888 48X48, 2000/CS-GAYLORD
0081558802463488 48X48,100_CASE WB
0081558802461088 48X48,100_CASE W
0081558802459788 48X48,100_CASE
0081558802457388 48X48,100_CASE
0081558802455988 45X45,100_CASE ZB
0081558802454288 45X45,100_CASE Z
0081558802453588 45X45,100_CASE
0081558802452888 45X45,100_CASE
0081558802451188 40X40, 3300/CS-GAYLORD
0081558802448188 40X40,3300/CS-GAYLORD
0081558802447488 40X40,100_CASE YB
0081558802446788 40X40,100_CASE Y
0081558802445088 40X40,100_CASE
0081558802444388 40X40,100_CASE
0081558802443688 36X36,150_CASE YB
0081558802441288 36X36,150_CASE Y
0081558802439988 36X36,150_CASE
0081558802437588 36X36,150_CASE
0081558802435188 32X32,6250/CS-GAYLORD
0081558802434488 32X32,250_CASE
0081558802432088 30X30,250_CASE XB
0081558802431388 30X30,250_CASE X
0081558802430688 30X30,250_CASE
0081558802429088 30X30 ,9000/ CS-GAYLORD
0081558802427688 30X30,250_CASE
0081558802426988 28X28,200_CASE XB
0081558802425288 28X28,200_CASE X
0081558802424588 24X24,500_CASE WB
0081558802422188 24X24,500_CASE W
0081558802420788 20X20,500_CASE VB
0081558802419188 20X20,500_CASE V
0081558802418488 18X18,500_CASE UB
0081558802417788 18X18,500_CASE U
0081558802416088 12X12,1000_CASE SB
0081558802414688 12X12,1000_CASE S
0081558802412277P 54X72,100_CASE Y
0081558802410877P 54X54,1800/CS-GAYLORD
0081558802408577P 54X54,100_CASE YB
0081558802406177P 54X54,100_CASE Y
0081558802403077P 48X48,2000/CS-GAYLORD
0081558802402377P 48X48,100_CASE W
0081558802400977P 45X45,250_CASE ZB

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