FDA.reportPublic FDA data

MONOSYN

Primary DI
04046964263903
Brand
MONOSYN
Company
B BRAUN SURGICAL SA
Model
C0025007
Catalog number
C0025007
Device description
MONOSYN QUICK UND 4/0(1,5)70CM DS19(M
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964263903PackageGS130In Commercial Distribution
04038653990726PrimaryGS10
04046963084196Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964263903040469642639034046964263903
04038653990726040386539907264038653990726
04046963084196040469630841964046963084196

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length70Centimeter

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
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

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

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Primary DI, Brand, Company table
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10705031472211VICRYLETHICON, LLCGAM2026-08-19
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10705031464407STRATAFIXETHICON, LLCGAM2023-03-24
10705031464414STRATAFIXETHICON, LLCGAM2023-03-24
10705031464421STRATAFIXETHICON, LLCGAM2023-03-24
10705031464438STRATAFIXETHICON, LLCGAM2023-03-24