FDA.reportPublic FDA data

Monomax

Primary DI
04046963989477
Brand
Monomax
Company
B BRAUN SURGICAL SA
Model
B9941128
Catalog number
B9941128
Device description
MONOMAX VLT 0 (3,5) 90CM HR48 USA(M)DDP
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
04046963989477PrimaryGS10
04046963989460Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963989477040469639894774046963989477
04046963989460040469639894604046963989460

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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length90Centimeter

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
04038653915408SteelexC0992070C09920702015-08-16
04038653911097SteelexG0617814G06178142015-08-20
04038653713929DafilonC0933350C09333502015-08-16
04046963634421PremileneC2090607C20906072015-08-17
04038653819362CatgutB0560570B05605702015-08-05
04038653822324CatgutB0563978B05639782015-11-01
04038653844357PremicronC0026016C00260162015-08-06
04046963462376PremicronB0026409B00264092015-11-05
04038653707621DagrofilC0840130C08401302015-08-16
04038653708567DagrofilC0842273C08422732015-08-16
04038653735068DagrofilG0341215G03412152015-08-20
04038653735105DagrofilG0341231G03412312015-08-20
04038653735181DagrofilG0341274G03412742015-08-20
04038653750337PremicronM0027706M00277062015-08-26
04038653750399PremicronM0027736M00277362015-08-26
04038653750436PremicronM0027756M00277562015-08-26
04038653750450PremicronM0027766M00277662015-08-26
04038653798865DagrofilC0346659C03466592015-08-13
04038653828104DagrofilB0842648B08426482015-11-01
04038653866960DagrofilC0852210C08522102015-08-16

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