FDA.report

MONOSYN

Primary DI
04046963730185
Brand
MONOSYN
Company
B BRAUN SURGICAL SA
Model
C0025115
Catalog number
C0025115
Device description
MONOSYN QUICK UNDY 4/0(1.5)45CM GR19(M)
Published
2018-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications

CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046955438457PackageGS130In Commercial Distribution
04046963730185PrimaryGS10
04046963730178Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046955438457040469554384574046955438457
04046963730185040469637301854046963730185
04046963730178040469637301784046963730178

GMDN Terms

TermDefinition
Polyester suture, bioabsorbable, monofilamentA 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 needle. 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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length45Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
511268005
Device count
36
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04046964732546MONOMAXB0041004B00410042018-05-03
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04046955081417OPTILENEB3095923B30959232022-10-04
04046955081653OPTILENEC3090272C30902722022-10-04
04046955081714OPTILENEC3090304C30903042022-10-04
04046964617331MONOSYNC2022015C20220152018-05-03
04046964618635MONOSYNC2022215C20222152018-05-03
04046964623615MONOSYNC2023424C20234242018-05-03
04046963043780DAFILONB0938920B09389202022-03-09
04046963117856DAFILONB0935890B09358902022-03-09
04046963929848DAFILONB0938905B09389052022-03-09
04046963042455DAFILONB0931640B09316402022-03-09
04046963043384DAFILONB0935739B09357392022-03-09
04038653945849SafilG1048388G10483882015-08-23
04046964028410MonomaxB9972005B99720052015-08-11
04046964028434MonomaxB9941967B99419672015-08-11
04046964028458MonomaxB9972004B99720042015-08-11
04046964028472MonomaxB9941966B99419662015-08-25
04046964066764MonomaxB9941249B99412492015-08-25
04046964066788MonomaxB9941258B99412582015-08-11

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