Cedrak

GUDID 18903389005231

Cerdak Aerocloth 100 x 200 mm

CARBORUNDUM UNIVERSAL LIMITED

Wound-nonadherent dressing, absorbent, sterile
Primary Device ID18903389005231
NIH Device Record Key99ddfde6-eea4-48c6-8d72-87fa953c3c2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCedrak
Version Model NumberCerdak Aerocloth
Company DUNS650051832
Company NameCARBORUNDUM UNIVERSAL LIMITED
Device Count10
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone3013255574
Emailbupet2015@gmail.com
Phone3013255574
Emailbupet2015@gmail.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN DRY PLACE IN ANY AMBIENT TEMPERATURE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN DRY PLACE IN ANY AMBIENT TEMPERATURE

Device Identifiers

Device Issuing AgencyDevice ID
GS118903389005231 [Package]
Contains: 58903389005239
Package: [10 Units]
In Commercial Distribution
GS128903389005238 [Unit of Use]
GS158903389005239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-18

Devices Manufactured by CARBORUNDUM UNIVERSAL LIMITED

58903389005017 - Cerdak2018-07-06 Cerdak Basic 30x30mm
18903389005026 - Cerdak2018-07-06 Cerdak Basic 50x25mm
18903389005033 - Cerdak 2018-07-06 Cerdak Basic 50x50mm
18903389005040 - Cerdak2018-07-06 Cerdak Basic 50x100mm
18903389005057 - Cerdak2018-07-06 Cerdak Basic 45x150mm
18903389005064 - Cerdak2018-07-06 Cerdak Basic 45x200mm
18903389005071 - Cerdak2018-07-06 Cerdak Basic 45x300mm
18903389005088 - Cerdak2018-07-06 Cerdak Basic 100x100mm

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