FUJIFILM medwork

Basic Information

• Brand Name: FUJIFILM medwork
• Primary DI: 04044503008145
• Version / Model: PUC1-A1-18-220-1
• Catalog Number: PUC1-A1-18-220-1
• Company Name: FUJIFILM medwork GmbH
• Labeler DUNS: 330797395
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-31
• Public Version: 1
• Public Version Date: 2026-04-08
• Public Version Status: New
• Public Device Record Key: 149020d2-5af6-42a3-8d9d-646f34782683

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCE	Adaptor, Catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52751	Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14044503008142	GS1	cardboard box	5	In Commercial Distribution
Primary	04044503008145	GS1