FDA.reportPublic FDA data

Premilene

Primary DI
04046964264214
Brand
Premilene
Company
B BRAUN SURGICAL SA
Model
C2090571
Catalog number
C2090571
Device description
PREMILENE 4/0 (1.5) 90CM 2XHRC17 CV
Published
2015-08-17
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
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
04046964264214PackageGS130Not in Commercial Distribution
04046963634322PrimaryGS10
04046963634315Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964264214040469642642144046964264214
04046963634322040469636343224046963634322
04046963634315040469636343154046963634315

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
Length90Centimeter

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
04038653700547AESCULAP102975410297542015-11-05
04046963835682AESCULAP105007110500712016-09-24
04046963535797NovosynC0068041C00680412015-08-12
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

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Primary DI, Brand, Company table
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10705031465015PROLENEETHICON, LLCGAW2026-08-17