STERIMED, INC. 1010378B3636VA

GUDID 00815588025709

STERISHEET NW 78B 36 X 36

STERIMED INC.

Sterilization packaging, single-use
Primary Device ID00815588025709
NIH Device Record Keybfec8225-500b-4315-bb4b-3680f1111d99
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERIMED, INC.
Version Model Number1010378B3636VA
Catalog Number1010378B3636VA
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
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us
Phone+1(843)388-8080
Emailmichelle.pendergraph@sterimed.us

Operating and Storage Conditions

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
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100815588025693 [Primary]
GS100815588025709 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-01
Device Publish Date2021-03-24

On-Brand Devices [STERIMED, INC.]

00815588025570260I 36X36,250
00815588025563260I 36X36,250
00815588025556260I 36X36 P/N 490 250
00815588025549260I 30X30,250
00815588025532260I 30X30,250
00815588025525260I 30X30 P/N 489 500
00815588025518260I 24X24,500
00815588025501260I 24X24,500
00815588025495260I 24X24 P/N 488 500
00815588025488260I 20X20,500
00815588025471260I 20X20,500
00815588025464260I 20X20 P/N 487 500
00815588025457260I 18X18,500
00815588025440260I 18X18,500
00815588025433260I 15X15,1000
00815588025426260I 15X15,1000
00815588025419260I 15X15 P/N 486 1000
00815588025402260I 12X12,1000
00815588025396260I 12X12,1000
00815588025099260I 36X36,5000 CS/GAYLORD
00815588025082260I 30X30,9000/CS-GAYLORD
00815588025075260I 24X24, 15000/CS-GAYLORD
00815588025068260I 20X20,20000/CS-GAYLORD
00815588025051260I 18X18, 26000/CS-GAYLORD
00815588025044260I 15X15, 40000/CS-GAYLORD
00815588025037260I 12X12, 50000/CS -GAYLORD
00815588025020260I 54X72,100
00815588025013260I 54X72,100
00815588025006260I 54X54,100
00815588024993260I 54X54,100
00815588024986260I 48X48,100
00815588024979260I 48X48,100
00815588024962260I 45X45,250
00815588024955260I 45X45,250
00815588024948260I 40X40,250
00815588024931260I 40X40,250
0081558802265452 24X24,10000/CS-GAYLORD
00815588025808STERISHEET NW 78B 24 X 24
00815588025785STERISHEET RF 60I 36 X 36
00815588025754STERISHEET RF 60I 30 X 30
00815588025747STERISHEET RF 60I 20 X 20
00815588025723STERISHEET NW 60B 40 X 40
00815588025709STERISHEET NW 78B 36 X 36
00815588025686STERISHEET NW 78B 48 X 48
00815588025662STERISHEET RF 60I 54 X 72
00815588025648STERISHEET RF 60I 54 X 54
00815588025624STERISHEET RF 60I 48 X 48
00815588025600STERISHEET CE 60B 40 X 40
00815588025846STERISHEET NW 60B 36 X 36
00815588025822STERISHEET NW 60B 54 X 54
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.