FDA.reportPublic FDA data

Safil

Primary DI
04038653938209
Brand
Safil
Company
B BRAUN SURGICAL SA
Model
C1048349
Catalog number
C1048349
Device description
SAFIL VIOLET 2/0 (3) 70CM HRT43 (M)
Published
2015-08-16
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
04046955468805PackageGS130In Commercial Distribution
04038653938209PrimaryGS10
04046963047115Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955468805040469554688054046955468805
04038653938209040386539382094038653938209
04046963047115040469630471154046963047115

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
Length70Centimeter

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
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
Primary DIBrandCompanyProduct codePublished
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08903837799302MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
10705031471863VICRYLETHICON, LLCGAM2026-08-19
10705031472150Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472167Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472211VICRYLETHICON, LLCGAM2026-08-19
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10705031464407STRATAFIXETHICON, LLCGAM2023-03-24
10705031464414STRATAFIXETHICON, LLCGAM2023-03-24
10705031464421STRATAFIXETHICON, LLCGAM2023-03-24
10705031464438STRATAFIXETHICON, LLCGAM2023-03-24