HEMOBLAST Bellows Laparoscopic Applicator

Basic Information

• Brand Name: HEMOBLAST Bellows Laparoscopic Applicator
• Primary DI: 03760193182668
• Version / Model: LAP01-US
• Catalog Number: LAP01-US
• Company Name: DILON TECHNOLOGIES FRANCE
• Labeler DUNS: 279346203
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-28
• Public Version: 3
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: effcbdef-41a2-4b53-8317-d39f75af687e

Device Description

HEMOBLAST Bellows Laparoscopic Applicator is intended for delivery of HEMOBLAST Bellows hemostatic powder to bleeding surgical sites through a 5mm or larger trocar.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
PMX	Absorbable Collagen Hemostatic Agent With Thrombin	General, Plastic Surgery	878.4490	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47201	Collagen haemostatic agent, non-antimicrobial	A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760193182668	GS1
Package	23760193182662	GS1	Box	6	In Commercial Distribution
Package	13760193182665	GS1	Carton	2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P170012	007

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dry Environment at room temperature