FDA.reportPublic FDA data

ImaJin

Primary DI
05708932057189
Brand
ImaJin
Company
Coloplast A/S
Model
AJ4573
Catalog number
AJ4573
Device description
ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 24 cm, Catheter Gauge 7 FR/CH.
Published
2022-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FADStent, ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932057189PackageGS11In Commercial Distribution
05708932057196PackageGS134In Commercial Distribution
05708932057172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932057189057089320571895708932057189
05708932057196057089320571965708932057196
05708932057172057089320571725708932057172

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge7French
Length24Centimeter
Outer Diameter0.09Inch
Outer Diameter2.3Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

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Primary DI, Brand, Company table
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08714729424123Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
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08714729766575Polaris™ UltraBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
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08714729776321Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776352Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
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08714729777465Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777540Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777601Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777663Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777670Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24