FDA.reportPublic FDA data

Monomax

Primary DI
04046963968670
Brand
Monomax
Company
B BRAUN SURGICAL SA
Model
B9941117
Catalog number
B9941117
Device description
MONOMAX VLT 0(3,5)150CMHR40S USALOOPMDDP
Published
2015-11-01
Public version status
Update
Distribution status
Not 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
NWJSuture, recombinant technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWJSuture, Recombinant TechnologyGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963968670PrimaryGS10
04046963968663Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963968670040469639686704046963968670
04046963968663040469639686634046963968663

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic thread made from a non-bioabsorbable polyester (e.g., polybutester) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length150Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
511268005
Device count
24
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653700547AESCULAP102975410297542015-11-05
04046963835682AESCULAP105007110500712016-09-24
04046963535797NovosynC0068041C00680412015-08-12
04046963535810NovosynC0068042C00680422015-08-12
04046963535995NovosynC0068051C00680512015-08-12
04046963536176NovosynC0068060C00680602015-08-12
04046963536213NovosynC0068062C00680622015-08-12
04046963536817NovosynC0068095C00680952015-08-12
04046963536831NovosynC0068096C00680962015-08-12
04046963536855NovosynC0068097C00680972015-08-12
04046963541477NovosynC0068416C00684162015-08-12
04046963550417NovosynC0069235C00692352015-08-13
04046963551797NovosynC0069421C00694212015-08-13
04046963529765NovosynB0058669B00586692015-08-05
04046963529789NovosynB0058670B00586702015-08-05
04046963529833NovosynB0058704B00587042015-08-05
04046963529857NovosynB0058705B00587052015-08-05
04046963529871NovosynB0058706B00587062015-08-05
04046963529895NovosynB0058707B00587072015-08-05
04046963529918NovosynB0058708B00587082015-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046964732546MONOMAXB BRAUN SURGICAL SANWJ2018-05-03
04046963489939MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963489953MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963489977MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963489991MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490317MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490331MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490379MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490386MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490409MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490423MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490447MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490461MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490485MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490508MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963490522MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963508784MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510107MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510121MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510145MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510169MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510183MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510220MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510244MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510268MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510282MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510305MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510329MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510343MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510367MONOMAXB BRAUN SURGICAL SANWJ2016-11-25