FDA.reportPublic FDA data

FUJIFILM medwork

Primary DI
04044503008145
Brand
FUJIFILM medwork
Company
FUJIFILM medwork GmbH
Model
PUC1-A1-18-220-1
Catalog number
PUC1-A1-18-220-1
Device description
Application catheters are used to apply haemostatic agents such as synthetic peptide materials or aqueous peptide solutions during endoscopic procedures in the upper and lower gastrointestinal tract.
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCEAdaptor, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCEAdaptor, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14044503008142PackageGS15In Commercial Distribution
04044503008145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404450300814214044503008142
04044503008145040445030081454044503008145

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-useA long flexible or rigid tube with an atraumatic tip intended to be used during an endoscopic/laparoscopic procedure to provide access for the administration of a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, polysaccharide) to a bleeding surgical site, typically to facilitate haemostasis and healing, in conjunction with an applicator such as a syringe [not included]. It is designed to be inserted into the body percutaneously, via a port or endoscope/laparoscope. It may have a single or dual-channel(s) for administration of one or two agent(s); a channel for connection to a gas pump for spraying may be incorporated. This is a single-use device.

Regulatory Flags#

DUNS number
330797395
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04044503035158FUJIFILM medworkFROG VAL1-F1-100VAL1-F1-1002022-07-07
04044503002341FUJIFILM medworkVAL1-G7-4-50-1VAL1-G7-4-50-12024-07-31
14044503002348FUJIFILM medworkVAL1-G7-4-50-1VAL1-G7-4-50-12024-07-31
04044503055828FUJIFILM medworkVAL1-G7-50VAL1-G7-502021-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503562256Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2025-04-30
16932503562253Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2025-04-30
00850052377007CLR Port InjectorCLR MedicalGCE2024-05-29
00860003054918CLR PortCLR MedicalGCE2024-05-29
00860003054994CLR Port CapCLR MedicalGCE2024-05-29
00850052377021CLR Port InjectorCLR MedicalGCE2024-05-29
00860003054956CLR PortCLR MedicalGCE2024-05-29
00850052377014CLR Port CapCLR MedicalGCE2024-05-29
00887709078017ICU MedicalICU MEDICAL, INC.GCE2023-08-30
00887709078024ICU MedicalICU MEDICAL, INC.GCE2023-08-30
10887709078014ICU MedicalICU MEDICAL, INC.GCE2023-08-30
10887709078021ICU MedicalICU MEDICAL, INC.GCE2023-08-30
00827002226760COOKCOOK INCORPORATEDGCE2022-12-08
00827002226777COOKCOOK INCORPORATEDGCE2022-12-08
M7525250520STRADIS HEALTHCARESTRADIS MEDICAL, LLCGCE2022-03-09
06932503562218Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562225Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562232Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562249Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562263Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562270Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562287Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562294Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562300Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562215MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562222MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562239MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562246MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562260MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562277MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31