HEMOBLAST Bellows Laparoscopic Applicator LAP01-US

GUDID 03760193182668

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

DILON TECHNOLOGIES FRANCE

Collagen haemostatic agent, non-antimicrobial
Primary Device ID03760193182668
NIH Device Record Keyeffcbdef-41a2-4b53-8317-d39f75af687e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEMOBLAST Bellows Laparoscopic Applicator
Version Model NumberLAP01-US
Catalog NumberLAP01-US
Company DUNS279346203
Company NameDILON TECHNOLOGIES FRANCE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com
Phone+33486573610
Emailcontact@biomup.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Dry Environment at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS103760193182668 [Primary]
GS113760193182665 [Package]
Contains: 23760193182662
Package: Carton [2 Units]
In Commercial Distribution
GS123760193182662 [Package]
Package: Box [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMXAbsorbable Collagen Hemostatic Agent With Thrombin

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-10-04
Device Publish Date2019-02-28

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