FDA.reportPublic FDA data

Optilene

Primary DI
04046964237034
Brand
Optilene
Company
B BRAUN SURGICAL SA
Model
C3090888
Catalog number
C3090888
Device description
OPTILENE 7/0 (0,5) 60CM 2XDR8 CV RCP
Published
2015-08-18
Public version status
Update
Distribution status
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
GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955489473PackageGS130In Commercial Distribution
04046964237034PrimaryGS10
04046964237027Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955489473040469554894734046955489473
04046964237034040469642370344046964237034
04046964237027040469642370274046964237027

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) 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 needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. 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
Length60Centimeter

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
04046964732546MONOMAXB0041004B00410042018-05-03
04038653926190SteelexG0992100G09921002015-08-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837747532Polypropylene sutureHEALTHIUM MEDTECH LIMITEDGAW2026-05-25
03661522101278COROLENE®PETERS SURGICALGAW2026-03-09
03661522101919COROLENE®PETERS SURGICALGAW2026-03-06
03661522101926COROLENE®PETERS SURGICALGAW2026-03-06
03661522101933COROLENE®PETERS SURGICALGAW2026-03-06
03661522101940COROLENE®PETERS SURGICALGAW2026-03-06
03661522101957COROLENE®PETERS SURGICALGAW2026-03-06
03661522101971COROLENE®PETERS SURGICALGAW2026-03-06
03661522101988COROLENE®PETERS SURGICALGAW2026-03-06
03661522101995COROLENE®PETERS SURGICALGAW2026-03-06
03661522102008COROLENE®PETERS SURGICALGAW2026-03-06
03661522102015COROLENE®PETERS SURGICALGAW2026-03-06
03661522102022COROLENE®PETERS SURGICALGAW2026-03-06
03661522102039COROLENE®PETERS SURGICALGAW2026-03-06
03661522102046COROLENE®PETERS SURGICALGAW2026-03-06
03661522102053COROLENE®PETERS SURGICALGAW2026-03-06
03661522102060COROLENE®PETERS SURGICALGAW2026-03-06
03661522102077COROLENE®PETERS SURGICALGAW2026-03-06
03661522102084COROLENE®PETERS SURGICALGAW2026-03-06
03661522102091COROLENE®PETERS SURGICALGAW2026-03-06
03661522102107COROLENE®PETERS SURGICALGAW2026-03-06
03661522102114COROLENE®PETERS SURGICALGAW2026-03-06
03661522102121COROLENE®PETERS SURGICALGAW2026-03-06
03661522102138COROLENE®PETERS SURGICALGAW2026-03-06
03661522102145COROLENE®PETERS SURGICALGAW2026-03-06
03661522102152COROLENE®PETERS SURGICALGAW2026-03-06
03661522102169COROLENE®PETERS SURGICALGAW2026-03-06
03661522102176COROLENE®PETERS SURGICALGAW2026-03-06
03661522102183COROLENE®PETERS SURGICALGAW2026-03-06
03661522102190COROLENE®PETERS SURGICALGAW2026-03-06