FDA.reportPublic FDA data

DAFILON

Primary DI
04038653890385
Brand
DAFILON
Company
B BRAUN SURGICAL SA
Model
B0932205
Catalog number
B0932205
Device description
DAFILON BLUE 4/0 (1.5) 45CM DS19
Published
2016-11-25
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
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
04038653890385PrimaryGS10
04045439053100Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653890385040386538903854038653890385
04045439053100040454390531004045439053100

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
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
24
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
04046964732546MONOMAXB0041004B00410042018-05-03
04038653926190SteelexG0992100G09921002015-08-20
04046955081417OPTILENEB3095923B30959232022-10-04
04046955081653OPTILENEC3090272C30902722022-10-04
04046955081714OPTILENEC3090304C30903042022-10-04
04046964617331MONOSYNC2022015C20220152018-05-03
04046964618635MONOSYNC2022215C20222152018-05-03
04046964623615MONOSYNC2023424C20234242018-05-03
04046963043780DAFILONB0938920B09389202022-03-09
04046963117856DAFILONB0935890B09358902022-03-09
04046963929848DAFILONB0938905B09389052022-03-09
04046963042455DAFILONB0931640B09316402022-03-09
04046963043384DAFILONB0935739B09357392022-03-09
04038653945849SafilG1048388G10483882015-08-23
04046964028410MonomaxB9972005B99720052015-08-11
04046964028434MonomaxB9941967B99419672015-08-11
04046964028458MonomaxB9972004B99720042015-08-11
04046964028472MonomaxB9941966B99419662015-08-25
04046964066764MonomaxB9941249B99412492015-08-25
04046964066788MonomaxB9941258B99412582015-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14946585362283CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362290CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362306CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362313CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362320CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362337CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362344CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362351CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362368CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362375CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362382CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362399CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362405CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362412CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
03661522103128CARDIONYL®PETERS SURGICALGAR2026-03-05
03661522103135CARDIONYL®PETERS SURGICALGAR2026-03-05
14946585347785CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348416CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348423CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348430CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348492CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585355292CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
04946585357374CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585357487CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585358002CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-02-10
14946585042222CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-01-26
14946585037143CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
04946585037153CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
14946585041935CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
14946585042208CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13