FDA.reportPublic FDA data

Optilene

Primary DI
04046964283598
Brand
Optilene
Company
B BRAUN SURGICAL SA
Model
C3096143
Catalog number
C3096143
Device description
OPTILENE 8/0(0,4)75CM 2XDR8B US175MCVRCP
Published
2015-08-19
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
04046964283598PrimaryGS10
04046964283581Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964283598040469642835984046964283598
04046964283581040469642835814046964283581

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
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
04038653700325B.BRAUN9960769960762015-07-22
04038653700349B.BRAUN9961739961732015-07-22
04038653844357PremicronC0026016C00260162015-08-06
04046963462376PremicronB0026409B00264092015-11-05
04038653750337PremicronM0027706M00277062015-08-26
04038653750450PremicronM0027766M00277662015-08-26
04038653871230PremicronM0027776M00277762015-08-26
04038653899678PremicronC0026845C00268452015-08-06
04038653900336PremicronC0026863C00268632015-08-06
04038653900480PremicronM0027705M00277052015-08-26
04038653900497PremicronM0027704M00277042015-11-11
04038653900695PremicronM0027722M00277222015-08-26
04038653900701PremicronM0027723M00277232015-08-26
04038653900725PremicronM0027791M00277912015-08-26
04038653911035PremicronM0027717M00277172015-08-26
04038653914050PremicronB0027082B00270822015-11-05
04038653921980PremicronB0026718B00267182015-11-05
04038653922246PremicronM0027605M00276052015-08-26
04038653928255PremicronB0026053B00260532015-08-05
04038653928279PremicronB0026075B00260752015-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10705031091412PROLENEETHICON, LLCGAW2026-08-17
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10705031095359PROLENEETHICON, LLCGAW2026-08-17