ImaJin

ImaJin ImaJin™. iso. Double loop ureteral stent kit. without eye on the straight section. Length 28 cm, Catheter Gauge 8 FR/CH.

Registry build 21.09.26
4manufacturers in China registered for this device type
219catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Zhejiang (1), Guangdong (1).

Chinese manufacturers registered for FDA product code FAD
Manufacturer City Province Registered as Device types
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Alton Shanghai Medical Instruments Co Ltd Shanghai Shanghai Complaint-file establishment 20
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13
Shenzhen Trious Medical Technology Co., Ltd. Shenzhen Guangdong Manufacturer 6

Record

Regulatory record for ImaJin
Listed by Coloplast A/S, Denmark
FDA product code FAD
Device type Stent, Ureteral
Device class Class 2
Regulation 21 CFR 876.4620
Establishment Specification developer, Manufacturer
Record published 2022-10-18
Record revised 2023-09-14 (version 2)

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Special storage condition: Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Packaging Retail box, shipper box of 34, shipper box of 19, shipper box of 12, retail box of 5
Sizes Length 16 to 30 cm; catheter gauge 6 to 12 Fr

Catalogue Numbers

Catalogue numbers for ImaJin
Catalogue number Size Status
AJ4271 Length 16 cm In distribution
AJ4773 Catheter Gauge 7 Fr In distribution
AJ4283 Catheter Gauge 8 Fr In distribution
BCHF85 Length 28 cm In distribution
AJ4271 Catheter Gauge 7 Fr In distribution
BCHF83 Length 24 cm In distribution
AJ5086 Catheter Gauge 8 Fr In distribution
BCHJ74 Catheter Gauge 7 Fr In distribution
AJ4W83 Length 24 cm In distribution
AJ5075 Length 28 cm In distribution
AJ4A73 Length 24 cm In distribution
AJ4285 Catheter Gauge 8 Fr In distribution
AJ5086 Catheter Gauge 8 Fr In distribution
AJ4873 Length 24 cm In distribution
AJ4C84 Length 26 cm In distribution
BCHJ64 Length 26 cm In distribution
BCHS71 Catheter Gauge 7 Fr In distribution
AJ4W84 Length 26 cm In distribution
AJ4C75 Length 28 cm In distribution
AJ4C62 Catheter Gauge 6 Fr In distribution
BCHS72 Length 20 cm In distribution
BCHF77 Length 22 cm In distribution
BCHJ61 Length 16 cm In distribution
AJ5081 Catheter Gauge 8 Fr In distribution
AJ4262 Catheter Gauge 6 Fr In distribution
AJ4A64 Catheter Gauge 6 Fr In distribution
AJ4A61 Length 16 cm In distribution
AJ4874 Catheter Gauge 7 Fr In distribution
AJ5072 Catheter Gauge 7 Fr In distribution
AJ4875 Catheter Gauge 7 Fr In distribution
AJ4Y85 Catheter Gauge 12 Fr In distribution
AJ4284 Length 26 cm In distribution
AJ4263 Length 24 cm In distribution
AJ4C73 Catheter Gauge 7 Fr In distribution
AJ4871 Length 16 cm In distribution
AJ4C74 Catheter Gauge 7 Fr In distribution
AJ4C76 Catheter Gauge 7 Fr In distribution
AJ4U85 Length 28 cm In distribution
AJ4885 Length 28 cm In distribution
AJ5074 Length 26 cm In distribution
AJ4C66 Length 30 cm In distribution
AJ5066 Catheter Gauge 6 Fr In distribution
BCHJ62 Catheter Gauge 6 Fr In distribution
AJ5082 Catheter Gauge 8 Fr In distribution
AJ4Y86 Catheter Gauge 8 Fr In distribution
AJ4574 Catheter Gauge 7 Fr In distribution
AJ5062 Length 20 cm In distribution
AJ4C84 Catheter Gauge 8 Fr In distribution
AJ4863 Catheter Gauge 6 Fr In distribution
AJ4C63 Length 24 cm In distribution
AJ4C65 Catheter Gauge 6 Fr In distribution
BCHS67 Catheter Gauge 6 Fr In distribution
AJ4884 Catheter Gauge 8 Fr In distribution
AJ4A63 Length 24 cm In distribution
AJ4263 Catheter Gauge 6 Fr In distribution
AJ4276 Catheter Gauge 7 Fr In distribution
BCHF82 Length 20 cm In distribution
BCHJ71 Catheter Gauge 7 Fr In distribution
BCHF81 Length 16 cm In distribution
BCHJ67 Length 22 cm In distribution
AJ4A75 Length 28 cm In distribution
AJ4261 Length 16 cm In distribution
AJ4584 Catheter Gauge 8 Fr In distribution
AJ4C76 Catheter Gauge 7 Fr In distribution
AJ4Y84 Catheter Gauge 8 Fr In distribution
AJ4C62 Length 20 cm In distribution
AJ5085 Length 28 cm In distribution
AJ4266 Length 30 cm In distribution
AJ4265 Length 28 cm In distribution
AJ4262 Length 20 cm In distribution
AJ4761 Catheter Gauge 6 Fr In distribution
AJ5076 Catheter Gauge 7 Fr In distribution
AJ5065 Catheter Gauge 6 Fr In distribution
AJ4W83 Length 24 cm In distribution
AJ4W85 Length 28 cm In distribution
AJ4281 Catheter Gauge 8 Fr In distribution
AJ4586 Length 30 cm In distribution
AJ4C72 Length 20 cm In distribution
BCHF73 Catheter Gauge 7 Fr In distribution
AJ4U75 Catheter Gauge 7 Fr In distribution
BCHS76 Length 30 cm In distribution
BCHF61 Length 16 cm In distribution
BCHJ86 Length 30 cm In distribution
AJ4W81 Length 16 cm In distribution
BCHF66 Catheter Gauge 6 Fr In distribution
AJ4265 Catheter Gauge 6 Fr In distribution
AJ5065 Length 28 cm In distribution
BCHJ63 Catheter Gauge 6 Fr In distribution
AJ4U74 Catheter Gauge 7 Fr In distribution
AJ4C75 Catheter Gauge 7 Fr In distribution
AJ4776 Catheter Gauge 7 Fr In distribution
AJ4865 Catheter Gauge 6 Fr In distribution
BCHS63 Catheter Gauge 6 Fr In distribution
AJ4A71 Catheter Gauge 7 Fr In distribution
BCHF75 Length 28 cm In distribution
BCHJ83 Catheter Gauge 8 Fr In distribution
AJ4C74 Catheter Gauge 7 Fr In distribution
AJ4W85 Length 28 cm In distribution
BCHJ76 Length 30 cm In distribution
AJ4C64 Catheter Gauge 6 Fr In distribution
AJ4573 Catheter Gauge 7 Fr In distribution
AJ4876 Catheter Gauge 7 Fr In distribution
BCHS77 Catheter Gauge 7 Fr In distribution
AJ5066 Length 30 cm In distribution
BCHF86 Length 30 cm In distribution
AJ4562 Length 20 cm In distribution
AJ5063 Catheter Gauge 6 Fr In distribution
AJ5063 Catheter Gauge 6 Fr In distribution
AJ5076 Length 30 cm In distribution
AJ4C85 Catheter Gauge 8 Fr In distribution
AJ4A76 Catheter Gauge 7 Fr In distribution
AJ4275 Catheter Gauge 7 Fr In distribution
BCHS74 Length 26 cm In distribution
AJ4Y85 Length 28 cm In distribution
AJ4861 Catheter Gauge 6 Fr In distribution
BCHJ65 Length 28 cm In distribution
AJ4C63 Length 24 cm In distribution
AJ4775 Length 28 cm In distribution
BCHS65 Catheter Gauge 6 Fr In distribution
AJ4C66 Length 30 cm In distribution
AJ5071 Catheter Gauge 7 Fr In distribution
AJ4282 Catheter Gauge 8 Fr In distribution
BCHJ77 Length 22 cm In distribution
AJ4C65 Length 28 cm In distribution
AJ4C86 Catheter Gauge 8 Fr In distribution
AJ5064 Catheter Gauge 6 Fr In distribution
BCHS75 Catheter Gauge 7 Fr In distribution
AJ5073 Catheter Gauge 7 Fr In distribution
BCHS85 Length 28 cm In distribution
AJ4576 Length 30 cm In distribution
AJ4564 Catheter Gauge 6 Fr In distribution
AJ5061 Length 16 cm In distribution
AJ4276 Length 30 cm In distribution
AJ4864 Catheter Gauge 6 Fr In distribution
AJ4285 Catheter Gauge 8 Fr In distribution
AJ4563 Catheter Gauge 6 Fr In distribution
BCHJ73 Length 24 cm In distribution
BCHJ72 Length 20 cm In distribution
AJ4A65 Length 28 cm In distribution
BCHS66 Length 30 cm In distribution
AJ4273 Length 24 cm In distribution
AJ5062 Length 20 cm In distribution
AJ4W81 Length 16 cm In distribution
AJ4C72 Length 20 cm In distribution
BCHF84 Length 26 cm In distribution
BCHF62 Catheter Gauge 6 Fr In distribution
AJ4264 Length 26 cm In distribution
AJ5073 Length 24 cm In distribution
AJ5084 Catheter Gauge 8 Fr In distribution
AJ4765 Length 28 cm In distribution
AJ5081 Catheter Gauge 8 Fr In distribution
AJ5083 Length 24 cm In distribution
AJ4774 Length 26 cm In distribution
AJ4283 Length 24 cm In distribution
AJ5071 Length 16 cm In distribution
AJ4C86 Catheter Gauge 8 Fr In distribution
AJ4A72 Length 20 cm In distribution
AJ4264 Length 26 cm In distribution
AJ4284 Catheter Gauge 8 Fr In distribution
BCHS64 Catheter Gauge 6 Fr In distribution
BCHJ85 Length 28 cm In distribution
AJ4286 Catheter Gauge 8 Fr In distribution
BCHJ82 Catheter Gauge 8 Fr In distribution
AJ4A74 Catheter Gauge 7 Fr In distribution
BCHF64 Catheter Gauge 6 Fr In distribution
BCHF72 Length 20 cm In distribution
AJ4A85 Catheter Gauge 8 Fr In distribution
AJ5085 Length 28 cm In distribution
AJ5084 Catheter Gauge 8 Fr In distribution
BCHF63 Length 24 cm In distribution
BCHS61 Length 16 cm In distribution
AJ5064 Catheter Gauge 6 Fr In distribution
AJ4W84 Length 26 cm In distribution
BCHF71 Catheter Gauge 7 Fr In distribution
BCHJ75 Length 28 cm In distribution
AJ4273 Length 24 cm In distribution
BCHF65 Length 28 cm In distribution
AJ4261 Catheter Gauge 6 Fr In distribution
AJ4763 Length 24 cm In distribution
BCHF76 Catheter Gauge 7 Fr In distribution
BCHJ81 Length 16 cm In distribution
AJ4565 Catheter Gauge 6 Fr In distribution
AJ4275 Length 28 cm In distribution
AJ4575 Length 28 cm In distribution
BCHF74 Length 26 cm In distribution
AJ5082 Length 20 cm In distribution
AJ5072 Length 20 cm In distribution
BCHJ84 Catheter Gauge 8 Fr In distribution
BCHS82 Catheter Gauge 8 Fr In distribution
AJ4272 Length 20 cm In distribution
AJ4274 Length 26 cm In distribution
BCHS62 Catheter Gauge 6 Fr In distribution
BCHS81 Catheter Gauge 8 Fr In distribution
AJ4W86 Catheter Gauge 8 Fr In distribution
AJ5074 Catheter Gauge 7 Fr In distribution
AJ4C64 Catheter Gauge 6 Fr In distribution
BCHS73 Catheter Gauge 7 Fr In distribution
AJ5075 Catheter Gauge 7 Fr In distribution
AJ4Y84 Length 26 cm In distribution
BCHS84 Length 26 cm In distribution
AJ4C85 Length 28 cm In distribution
AJ5061 Catheter Gauge 6 Fr In distribution
AJ4266 Catheter Gauge 6 Fr In distribution
AJ4764 Length 26 cm In distribution
BCHF67 Length 22 cm In distribution
BCHS86 Length 30 cm In distribution
AJ4282 Length 20 cm In distribution
AJ4272 Catheter Gauge 7 Fr In distribution
BCHJ66 Length 30 cm In distribution
AJ4274 Catheter Gauge 7 Fr In distribution
AJ4281 Catheter Gauge 8 Fr In distribution
BCHS83 Catheter Gauge 8 Fr In distribution
AJ4A84 Length 26 cm In distribution
AJ4Y86 Length 30 cm In distribution
AJ4W86 Length 30 cm In distribution
AJ4585 Catheter Gauge 8 Fr In distribution
AJ4286 Length 30 cm In distribution
AJ5083 Length 24 cm In distribution
AJ4C73 Catheter Gauge 7 Fr In distribution

Same Product Code

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Showing 12 of 131. All products under Stent, Ureteral

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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