FDA.report

Safil

Primary DI
04038653965533
Brand
Safil
Company
B BRAUN SURGICAL SA
Model
X1048037
Catalog number
X1048037
Device description
SAFIL VIOLET 0 (3.5) 70CM HR22S (M)
Published
2016-07-13
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

Related Records

Product Codes

CodeName
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications

CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653965533PrimaryGS10
04045439054831Unit of UseGS10

GMDN Terms

TermDefinition
Polyester suture, bioabsorbable, multifilament, non-antimicrobialA 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 device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length70Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
511268005
Device count
4
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

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04046964732546MONOMAXB0041004B00410042018-05-03
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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

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