FDA.report

ImaJin

Primary DI
05708932056564
Brand
ImaJin
Company
Coloplast A/S
Model
AJ4262
Catalog number
AJ4262
Device description
ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 20 cm, Catheter Gauge 6 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

Related Records

Contact Domains

Product Codes

CodeName
FADStent, ureteral

Product Code Classifications

CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05708932056557PackageGS11In Commercial Distribution
05708932056564PackageGS134In Commercial Distribution
05708932056540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05708932056557057089320565575708932056557
05708932056564057089320565645708932056564
05708932056540057089320565405708932056540

GMDN Terms

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

TypeValueUnit
Catheter Gauge6French
Length20Centimeter
Outer Diameter0.08Inch
Outer Diameter2Millimeter

Sterilization Methods

Method

Contacts

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

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