FDA.reportPublic FDA data

OPTILENE

Primary DI
04046964795640
Brand
OPTILENE
Company
B BRAUN SURGICAL SA
Model
C3095861
Catalog number
C3095861
Device description
OPTILENE 6/0 (0,7) 75CM HR10F CV RCP
Published
2018-05-03
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
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
04046964795640PrimaryGS10
04046964795633Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964795640040469647956404046964795640
04046964795633040469647956334046964795633

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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length75Centimeter

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653741502SilkamG0760412G07604122015-08-20
04038653741526SilkamG0760420G07604202015-08-20
04038653741601SilkamG0760480G07604802015-08-20
04038653741700SilkamG0760986G07609862015-08-20
04038653741786SilkamG0762040G07620402015-08-20
04038653741816SilkamG0762067G07620672015-08-20
04038653741830SilkamG0762075G07620752015-08-20
04038653741854SilkamG0762083G07620832015-08-20
04038653741892SilkamG0762113G07621132015-08-20
04038653741915SilkamG0762121G07621212015-08-20
04038653742196SilkamG0762350G07623502015-08-20
04038653742257SilkamG0762423G07624232015-08-20
04038653742271SilkamG0762431G07624312015-08-20
04038653742776SilkamG0764647G07646472015-08-20
04038653742936SilkamG0765198G07651982015-08-20
04038653742950SilkamG0765201G07652012015-08-20
04038653742974SilkamG0765210G07652102015-08-20
04038653742998SilkamG0765228G07652282015-08-20
04038653792757SilkamC0262099C02620992015-08-13
04038653792795SilkamC0262102C02621022015-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08903837224538TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837224552TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837337238TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
10705031091412PROLENEETHICON, LLCGAW2026-08-17
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10705031465015PROLENEETHICON, LLCGAW2026-08-17