FDA.reportPublic FDA data

FSSB Nylon Suture

Primary DI
EFSBA023PA2
Brand
FSSB Nylon Suture
Company
FSSB Chirurgische Nadeln GmbH
Model
A023PA
Published
2016-09-21
Public version status
Update
Distribution status
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
GARSuture, Nonabsorbable, Synthetic, Polyamide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EFSBA023PA2PrimaryHIBCC0
EFSBA023PA1Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. 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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497745927990info@fssb.de

Regulatory Flags#

DUNS number
314275413
Device count
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EFSB0819AE2FSSB Nylon Suture0819AE2016-09-21
EFSB1825AE2FSSB Nylon Suture1825AE2016-09-19
EFSB2510AE2FSSB Nylon Suture2510AE2016-09-19
EFSB2525AE2FSSB Nylon Suture2525AE2016-09-19
EFSB2534AE2FSSB Nylon Suture2534AE2016-09-19
EFSB2681AE2FSSB Nylon Suture2681AE2016-09-21
EFSB2683AE2FSSB Nylon Suture2683AE2016-09-21
EFSB2687AE2FSSB Nylon Suture2687AE2016-09-21
EFSB7718AE2FSSB Nylon Suture7718AE2017-07-17
EFSB7756AE2FSSB Nylon Suture7756AE2016-09-21
EFSB7770AE2FSSB Nylon Suture7770AE2017-07-17
EFSB9000AE2FSSB Nylon Suture9000AE2016-09-21
EFSB9001AE2FSSB Nylon Suture9001AE2016-09-21
EFSB9061AE2FSSB Nylon Suture9061AE2017-07-21
EFSBA016PA2FSSB Nylon SutureA016PA2016-09-21
EFSBA017PA2FSSB Nylon SutureA017PA2016-09-21
EFSBA021PA2FSSB Nylon SutureA021PA2016-09-21
EFSBA025PA2FSSB Nylon SutureA025PA2016-09-21
EFSBA026PA2FSSB Nylon SutureA026PA2016-09-21
EFSBA131PA2FSSB Nylon SutureA131PA2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031088054ETHILONETHICON, LLCGAR2026-07-03
10705031089600ETHILONETHICON, LLCGAR2026-07-03
10705031097018ETHILONETHICON, LLCGAR2026-07-03
10705031099975ETHILONETHICON, LLCGAR2026-07-03
07757093013747SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013068SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013280SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013563SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013587SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013600SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013877SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013952SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014041SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014096SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014188SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014362SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014393SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014560SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014713SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014744SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014768SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014881SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014898SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014911SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015048SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015093SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015147SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015253SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015277SUTUMEDUnilene S.A.C.GAR2023-01-06