FDA.reportPublic FDA data

Safil

Primary DI
04045439032112
Brand
Safil
Company
B BRAUN SURGICAL SA
Model
C1049207
Catalog number
C1049207
Device description
SAFIL UNDYED 5/0 (1) 45CM DS12 (M)
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04045439032112PrimaryGS10
04046963065898Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04045439032112040454390321124045439032112
04046963065898040469630658984046963065898

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable needle. 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
Length45Centimeter

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
04038653911097SteelexG0617814G06178142015-08-20
04038653906703SteelexG0617741G06177412015-08-20
04038653910113SteelexG0617733G06177332015-08-20
04038653910120SteelexG0617750G06177502015-08-20
04038653910137SteelexG0617717G06177172015-08-20
04038653910144SteelexG0617776G06177762015-08-20
04038653910502SteelexG0617784G06177842015-08-20
04038653910519SteelexG0617792G06177922015-08-20
04038653913527SteelexG0617742G06177422015-08-20
04038653916405SteelexG0617795G06177952015-08-20
04045439016747SteelexG0617802G06178022015-08-20
04046963374280SteelexG0617135G06171352015-08-20
04046963374310SteelexG0617134G06171342015-08-20
04038653741502SilkamG0760412G07604122015-08-20
04038653741526SilkamG0760420G07604202015-08-20
04038653741601SilkamG0760480G07604802015-08-20
04038653741700SilkamG0760986G07609862015-08-20
04038653741786SilkamG0762040G07620402015-08-20
04038653741816SilkamG0762067G07620672015-08-20
04038653741830SilkamG0762075G07620752015-08-20

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Primary DI, Brand, Company table
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