FDA.reportPublic FDA data

HEMOBLAST Bellows Laparoscopic Applicator

Primary DI
03760193182668
Brand
HEMOBLAST Bellows Laparoscopic Applicator
Company
DILON TECHNOLOGIES FRANCE
Model
LAP01-US
Catalog number
LAP01-US
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.
Published
2019-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMXAbsorbable Collagen Hemostatic Agent With Thrombin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMXAbsorbable Collagen Hemostatic Agent With ThrombinGeneral, Plastic Surgery3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P170012007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170012007HEMOBLAST™ BellowsDilon Technologies, Inc.2017-12-15PMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13760193182665PackageGS12In Commercial Distribution
23760193182662PackageGS16In Commercial Distribution
03760193182668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1376019318266513760193182665
2376019318266223760193182662
03760193182668037601931826683760193182668

GMDN Terms#

Term, Definition table
TermDefinition
Collagen haemostatic agent, non-antimicrobialA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Dry Environment at room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33486573610contact@biomup.com
757-269-4910info@dilon.com

Regulatory Flags#

DUNS number
279346203
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760193182705HEMOBLAST BellowsBQF02BQF02-US2018-03-19
03760193181975SALVIN RENOVIXMCG 11 12 URENOVIX-15x252016-02-25
03760193181982SALVIN RENOVIXMCG 12 23 URENOVIX-20x302016-02-25
03760193181999SALVIN RENOVIXMCG 13 34 URENOVIX-30x402016-02-25
03760193182019COVAORTHO-NERVEMCG 11 12 VCOVO122016-02-25
03760193182026COVAORTHO-NERVEMCG 12 23 VCOVO232016-02-25
03760193182033COVAORTHO-NERVEMCG 13 34 VCOVO342016-02-25
03760193182040COVAORTHO-NERVEMCG 14 46 VCOVO462016-02-25
03760193182057COVAORTHO-NERVEMCG 15 68 VCOVO682016-11-28
03760193182194COVAMAXMCG 11 12 AACOV12DUS2016-02-22
03760193182200COVAMAXMCG 12 23 AACOV23DUS2016-02-25
03760193182217COVAMAXMCG 13 34 AACOV34DUS2016-02-25
03760193182552COVA ORTHO NERVEMCG 11 12 ADCOUS122016-11-28
03760193182569COVA ORTHO NERVEMCG 12 23 ADCOUS232016-11-28
03760193182576COVA ORTHO NERVEMCG 13 34 ADCOUS342016-11-28
03760193182583COVA ORTHO NERVEMCG 14 46 ADCOUS462016-11-28
03760193182590COVA ORTHO NERVEMCG 15 68 ADCOUS682016-11-28
03760193182088COVAMESHMSH 08 D12 VCVM12RUS2016-02-25
03760193182095COVAMESHMSH 09 1510 VCVM1510US2016-02-26
03760193182101COVAMESHMSH 10 2015 VCVM2015US2016-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00085412827896FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2023-05-09
50085412827891FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2023-05-09
00085412827957FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2022-04-18
50085412827952FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2022-04-18
00085412639598FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-07-31
50085412639593FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-07-31
00085412639604FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-07-30
50085412639609FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-07-30
00085412656304FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-05-31
50085412656309FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-05-31
03760193182705HEMOBLAST BellowsDILON TECHNOLOGIES FRANCEPMX2018-03-19
00085412096100Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2017-10-09
00085412096124Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2017-10-09
50085412096129Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2017-10-09
00085412532738FlosealBAXTER HEALTHCARE CORPORATIONPMX2017-04-12
00085412532868FlosealBAXTER HEALTHCARE CORPORATIONPMX2017-04-12
50085412532733FlosealBAXTER HEALTHCARE CORPORATIONPMX2017-04-12
50085412532863FlosealBAXTER HEALTHCARE CORPORATIONPMX2017-04-12
00085412096094Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2015-05-22
00085412096117Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2015-05-22