ImaJin AJ4C65

GUDID 05701780334402

Coloplast A/S

Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use
Primary Device ID05701780334402
NIH Device Record Key45ffefe6-425c-4ef2-91b1-fb78a0fd0cde
Commercial Distribution StatusIn Commercial Distribution
Brand NameImaJin
Version Model NumberAJ4C65
Catalog NumberAJ4C65
Company DUNS305524696
Company NameColoplast A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com

Device Dimensions

Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French
Length28 Centimeter
Catheter Gauge6 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.

Device Identifiers

Device Issuing AgencyDevice ID
GS105701780334396 [Primary]
GS105701780334402 [Package]
Contains: 05701780334396
Package: Retail Box [5 Units]
In Commercial Distribution
GS105701780334419 [Package]
Package: Shipper Box [12 Units]
In Commercial Distribution

FDA Product Code

FADStent, ureteral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-22
Device Publish Date2024-04-12

On-Brand Devices [ImaJin]

05708932060004ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 30 cm, Catheter Gauge 8 FR/CH.
05708932059978ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge 8 FR/CH.
05708932059947ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 26 cm, Catheter Gauge
05708932059831ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 30 cm, Catheter Gauge 7 FR/CH.
05708932059800ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge
05708932059770ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 26 cm, Catheter Gauge
05708932059732ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 24 cm, Catheter Gauge
05708932059718ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 20 cm, Catheter Gauge 7 FR/CH.
05708932059640ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 30 cm, Catheter Gauge 6 FR/CH.
05708932059619ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge
05708932059589ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 26 cm, Catheter Gauge
05708932059565ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 24 cm, Catheter Gauge
05708932059534ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 20 cm, Catheter Gauge
05708932059466ImaJin ImaJin™. iso. Double loop ureteral stent kit. without eye on the straight section. Le
05708932059404ImaJin ImaJin™. iso. Double loop ureteral stent kit. without eye on the straight section. Le
05708932058834ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 30 cm, Catheter Gauge 8 FR/CH.
05708932058803ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge
05708932058773ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 26 cm, Catheter Gauge
05708932058759ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 30 cm, Catheter Gauge
05708932058711ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge
05708932058681ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 26 cm, Catheter Gauge
05708932058650ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 24 cm, Catheter Gauge
05708932058629ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 20 cm, Catheter Gauge 7 FR/CH.
05708932058599ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 30 cm, Catheter Gauge
05708932058568ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge
05708932058544ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 26 cm, Catheter Gauge
05708932058513ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 24 cm, Catheter Gauge
05708932058483ImaJin / ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 20 cm, Catheter Gauge
05708932058452ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge 8 FR/CH.
05708932058414ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 26 cm, Catheter Gauge 8 FR/CH.
05708932058360ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge 7 FR/CH.
05708932058292ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 24 cm, Catheter Gauge 7 FR/CH.
05708932058261ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 20 cm, Catheter Gauge 7 FR/CH.
05708932058230ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 16 cm, Catheter Gauge 7 FR/CH.
05708932058209ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge 6 FR/CH.
05708932058179ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 26 cm, Catheter Gauge 6 FR/CH.
05708932058117ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 16 cm, Catheter Gauge 6 FR/CH.
05708932057943ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge 8 FR/CH.
05708932057882ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 30 cm, Catheter Gauge 7 FR/CH.
05708932057851ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge 7 FR/CH.
05708932057813ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 26 cm, Catheter Gauge 7 FR/CH.
05708932057790ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 24 cm, Catheter Gauge 7 FR/CH.
05708932057769ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 16 cm, Catheter Gauge 7 FR/CH.
05708932057721ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge 6 FR/CH.
05708932057707ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 26 cm, Catheter Gauge 6 FR/CH.
05708932057646ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 16 cm, Catheter Gauge 6 FR/CH.
05708932057608ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 30 cm, Catheter Gauge 7 FR/CH.
05708932057578ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge 7 FR/CH.
05708932057547ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 26 cm, Catheter Gauge 7 FR/CH.
05708932057523ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 24 cm, Catheter Gauge 7 FR/CH.

Trademark Results [ImaJin]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMAJIN
IMAJIN
86031603 not registered Live/Pending
Bangarang LLC
2013-08-07
IMAJIN
IMAJIN
85656006 not registered Dead/Abandoned
Bangarang, LLC
2012-06-19
IMAJIN
IMAJIN
79165734 4824578 Live/Registered
Coloplast A/S
2015-03-09
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