MONOMAX

Primary DI: 04046963829704
Brand: MONOMAX
Company: B BRAUN SURGICAL SA
Model: B0041982
Catalog number: B0041982
Device description: MONOMAX VIOLET 3/0 (2) 70CM HR17 (M)
Published: 2016-11-25
Public version status: Update
Distribution status: 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

bbraun.com

Product Codes

Code	Name
NWJ	Suture, recombinant technology

Product Code Classifications

Code	Device	Specialty	Class
NWJ	Suture, Recombinant Technology	General, Plastic Surgery	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
04046963829704	Primary	GS1	0
04046963829698	Unit of Use	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
04046963829704	04046963829704	4046963829704
04046963829698	04046963829698	4046963829698

GMDN Terms

Term	Definition
Polyester suture, bioabsorbable, monofilament, non-antimicrobial	A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) 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.

Term

Definition

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) 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

Type	Value	Unit
Device Size Text, specify	0
Device Size Text, specify	0
Length	70	Centimeter

Storage And Handling

Type	Low	High	Condition
Storage Environment Temperature	0 Degrees Celsius	50 Degrees Celsius

Sterilization Methods

Method

Contacts

Phone	Email
+1(800)282-9000	GUDID.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

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04046964732546	MONOMAX	B0041004	B0041004	2018-05-03
04038653926190	Steelex	G0992100	G0992100	2015-08-20
04046955081417	OPTILENE	B3095923	B3095923	2022-10-04
04046955081653	OPTILENE	C3090272	C3090272	2022-10-04
04046955081714	OPTILENE	C3090304	C3090304	2022-10-04
04046964617331	MONOSYN	C2022015	C2022015	2018-05-03
04046964618635	MONOSYN	C2022215	C2022215	2018-05-03
04046964623615	MONOSYN	C2023424	C2023424	2018-05-03
04046963043780	DAFILON	B0938920	B0938920	2022-03-09
04046963117856	DAFILON	B0935890	B0935890	2022-03-09
04046963929848	DAFILON	B0938905	B0938905	2022-03-09
04046963042455	DAFILON	B0931640	B0931640	2022-03-09
04046963043384	DAFILON	B0935739	B0935739	2022-03-09
04038653945849	Safil	G1048388	G1048388	2015-08-23
04046964028410	Monomax	B9972005	B9972005	2015-08-11
04046964028434	Monomax	B9941967	B9941967	2015-08-11
04046964028458	Monomax	B9972004	B9972004	2015-08-11
04046964028472	Monomax	B9941966	B9941966	2015-08-25
04046964066764	Monomax	B9941249	B9941249	2015-08-25
04046964066788	Monomax	B9941258	B9941258	2015-08-11

Other Devices Sharing Product Codes

Primary DI	Brand	Company	Product code	Published
04046964732546	MONOMAX	B BRAUN SURGICAL SA	NWJ	2018-05-03
04046963489939	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963489953	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963489977	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963489991	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963490317	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963490331	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963490379	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963490386	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963490409	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963490423	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963490447	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963490461	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963490485	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963490508	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963490522	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963508784	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510107	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510121	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510145	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510169	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510183	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510220	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510244	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510268	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510282	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510305	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510329	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510343	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25
04046963510367	MONOMAX	B BRAUN SURGICAL SA	NWJ	2016-11-25