FDA.report

Premicron

Primary DI
04046963676681
Brand
Premicron
Company
B BRAUN SURGICAL SA
Model
X0120051
Catalog number
X0120051
Device description
PREMICRON GREEN 2/0 (3) 17X45CM DDP
Published
2015-08-27
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

Contact Domains

Product Codes

CodeName
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Product Code Classifications

CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046963676681PrimaryGS10
04046963464929Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046963676681040469636766814046963676681
04046963464929040469634649294046963464929

GMDN Terms

TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. 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
Length45Centimeter

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

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
10810020085218HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411768HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411775HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411782HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411799HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
00840277411808HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
03661522100837CARDIOXYL®PETERS SURGICALGAT2026-03-09
03661522100844CARDIOXYL®PETERS SURGICALGAT2026-03-09
03661522100851CARDIOXYL®PETERS SURGICALGAT2026-03-09
03661522101285CARDIOXYL®PETERS SURGICALGAT2026-03-09
03661522101391CARDIOXYL®PETERS SURGICALGAT2026-03-05
03661522103142CARDIOXYL®PETERS SURGICALGAT2026-03-05
07899258695846Meniscus VersaflexGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-03-03
07901125601062Meniscus VersaflexGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-03-03
00840277411068HS FiberRIVERPOINT MEDICAL, LLCGAT2026-01-26
00840277411396HS FiberRIVERPOINT MEDICAL, LLCGAT2026-01-13
10840277411409HS FiberRIVERPOINT MEDICAL, LLCGAT2026-01-13
00810129093193HyperSutureThreadstone LLCGAT2026-01-09
00810129092363HyperSutureThreadstone LLCGAT2026-01-08
10888867472089Arthrex®ARTHREX, INC.GAT2026-01-07
00888867472099Arthrex®ARTHREX, INC.GAT2026-01-07
00840277410023ProZip Knotless ImplantRIVERPOINT MEDICAL, LLCGAT2026-01-06
00840277410030ProZip Knotless ImplantRIVERPOINT MEDICAL, LLCGAT2026-01-06
10840277410068ProZip Knotless ImplantRIVERPOINT MEDICAL, LLCGAT2026-01-06
10840277410075ProZip Knotless ImplantRIVERPOINT MEDICAL, LLCGAT2026-01-06
10888867459141Arthrex®ARTHREX, INC.GAT2025-12-26
10888867459158Arthrex®ARTHREX, INC.GAT2025-12-26
00888867459205Arthrex®ARTHREX, INC.GAT2025-12-26
00888867459212Arthrex®ARTHREX, INC.GAT2025-12-26
00810129092271HyperSutureThreadstone LLCGAT2025-12-09