FDA.reportPublic FDA data

Premilene

Primary DI
04038653902927
Brand
Premilene
Company
B BRAUN SURGICAL SA
Model
G0090168
Catalog number
G0090168
Device description
PREMILENE 8/0(0.4) 2X75CM 2XDRC8 CV LPCE
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
04038653902927PrimaryGS10
04046963053086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653902927040386539029274038653902927
04046963053086040469630530864046963053086

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
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653915408SteelexC0992070C09920702015-08-16
04038653911097SteelexG0617814G06178142015-08-20
04038653713929DafilonC0933350C09333502015-08-16
04046963634421PremileneC2090607C20906072015-08-17
04038653819362CatgutB0560570B05605702015-08-05
04038653822324CatgutB0563978B05639782015-11-01
04038653844357PremicronC0026016C00260162015-08-06
04046963462376PremicronB0026409B00264092015-11-05
04038653707621DagrofilC0840130C08401302015-08-16
04038653708567DagrofilC0842273C08422732015-08-16
04038653735068DagrofilG0341215G03412152015-08-20
04038653735105DagrofilG0341231G03412312015-08-20
04038653735181DagrofilG0341274G03412742015-08-20
04038653750337PremicronM0027706M00277062015-08-26
04038653750399PremicronM0027736M00277362015-08-26
04038653750436PremicronM0027756M00277562015-08-26
04038653750450PremicronM0027766M00277662015-08-26
04038653798865DagrofilC0346659C03466592015-08-13
04038653828104DagrofilB0842648B08426482015-11-01
04038653866960DagrofilC0852210C08522102015-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837037824TruleneHEALTHIUM MEDTECH LIMITEDGAW2024-07-11
07757093024767SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024828SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024859SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024873SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025092SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025115SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025146SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025184SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025290SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025313SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025467SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025610SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025702SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025726SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025740SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025832SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026044SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026136SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026150SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026280SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026518SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093680543SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093023760SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023838SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023869SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023890SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023968SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024033SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024101SUTUMEDUnilene S.A.C.GAW2023-01-07