FDA.reportPublic FDA data

Novosyn

Primary DI
04046963535797
Brand
Novosyn
Company
B BRAUN SURGICAL SA
Model
C0068041
Catalog number
C0068041
Device description
NOVOSYN VIOLET 3/0 (2) 70CM HR26 (M) DDP
Published
2015-08-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
04046964263941PackageGS130Not in Commercial Distribution
04046963535797PrimaryGS10
04046963535780Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964263941040469642639414046964263941
04046963535797040469635357974046963535797
04046963535780040469635357804046963535780

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester 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
Length0

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
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
04046963529932NovosynB0058709B00587092015-08-05
04046963529956NovosynB0059669B00596692015-08-05
04046963529970NovosynB0059670B00596702015-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08903837337252PDSYNTHHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837402349TruglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799265MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799289MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799302MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
10705031471863VICRYLETHICON, LLCGAM2026-08-19
10705031472150Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472167Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472211VICRYLETHICON, LLCGAM2026-08-19
10705031472228VICRYLETHICON, LLCGAM2026-08-19
10705031464278STRATAFIXETHICON, LLCGAM2023-03-24
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10705031464353STRATAFIXETHICON, LLCGAM2023-03-24
10705031464360STRATAFIXETHICON, LLCGAM2023-03-24
10705031464377STRATAFIXETHICON, LLCGAM2023-03-24
10705031464384STRATAFIXETHICON, LLCGAM2023-03-24
10705031464391STRATAFIXETHICON, LLCGAM2023-03-24
10705031464407STRATAFIXETHICON, LLCGAM2023-03-24
10705031464414STRATAFIXETHICON, LLCGAM2023-03-24
10705031464421STRATAFIXETHICON, LLCGAM2023-03-24
10705031464438STRATAFIXETHICON, LLCGAM2023-03-24