FDA.reportPublic FDA data

Cerdak

Primary DI
18903389005163
Brand
Cerdak
Company
CARBORUNDUM UNIVERSAL LIMITED
Model
Cerdak Aerocloth
Device description
Cerdak Aerocloth 50 x 50 mm
Published
2018-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153138000Cerdak BasicBu Polysciences Equipment & Trading, LLC2017-06-23FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18903389005163PackageGS110In Commercial Distribution
58903389005161PrimaryGS10
28903389005160Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1890338900516318903389005163
5890338900516158903389005161
2890338900516028903389005160

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, sterileA sterile wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel) that prevents adherence to the wound bed, thereby decreasing the potential for wound trauma; it does not contain an antimicrobial agent. It is typically used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN DRY PLACE IN ANY AMBIENT TEMPERATURE

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3013255574bupet2015@gmail.com

Regulatory Flags#

DUNS number
650051832
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
58903389005024CerdakCerdak Basic 2018-01-11
58903389005031Cerdak Cerdak Basic 2018-01-11
58903389005048CerdakCerdak Basic 2018-01-11
58903389005055CerdakCerdak Basic 2018-01-11
58903389005062CerdakCerdak Basic 2018-01-11
58903389005079CerdakCerdak Basic 2018-01-11
58903389005086CerdakCerdak Basic2018-01-11
58903389005093CerdakCerdak Basic2018-01-11
58903389005109CerdakCerdak Basic2018-01-11
58903389005116CerdakCerdak Basic2018-01-11
58903389005123CerdakCerdak Basic2018-01-11
58903389005130CerdakCerdak Basic2018-01-11
58903389005147CerdakCerdak Aerocloth2018-01-18
58903389005154CerdakCerdak Aerocloth2018-01-18
58903389005161CerdakCerdak Aerocloth2018-01-18
58903389005178CerdakCerdak Aerocloth2018-01-18
58903389005185CerdakCerdak Aerocloth2018-01-18
58903389005192CerdakCerdak Aerocloth2018-01-18
58903389005208CerdakCerdak Aerocloth2018-01-18
58903389005215CerdakCerdak Aerocloth2018-01-18

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