FDA.reportPublic FDA data

MONOMAX

Primary DI
04046963510305
Brand
MONOMAX
Company
B BRAUN SURGICAL SA
Model
B0041086
Catalog number
B0041086
Device description
MONOMAX VIOLET 2/0 (3) 70CM HR40S (M)
Published
2016-11-25
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
04046963510305PrimaryGS10
04046963510299Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963510305040469635103054046963510305
04046963510299040469635102994046963510299

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilament, non-antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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
Length70Centimeter

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
04046963510329MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510343MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510367MONOMAXB BRAUN SURGICAL SANWJ2016-11-25
04046963510381MONOMAXB BRAUN SURGICAL SANWJ2016-11-25