Olympus

Primary DI: 04042761030953
Brand: Olympus
Company: OLYMPUS Winter & Ibe GmbH
Model: WA95042A
Catalog number: WA95042A
Published: 2016-09-22
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#

xx.xx

Product Codes#

Code, Name table
Code	Name
FGE	Catheter, Biliary, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K050502	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K050502	000	SINGLE USE BALLOON DILATOR MAXPASSTM	Olympus Winter & Ibe GmbH	2005-07-08	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
04042761030953	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
04042761030953	04042761030953	4042761030953

GMDN Terms#

Term, Definition table
Term	Definition
Endoscopic-access dilator, single-use	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.

Contacts#

Phone, Email table
Phone	Email
800-401-1086	xx@xx.xx

Regulatory Flags#

DUNS number: 316957240
Device count: 1
Lot or batch: true
Expiration date on label: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
04042761082297	Olympus	WA03300A	WA03300A	2016-09-22
04042761082303	Olympus	WA03310A	WA03310A	2016-09-22
14042761083369	Olympus	WT645010	WT645010	2023-06-20
04042761083324	Olympus	WT806450	WT806450	2023-01-27
04042761081757	Olympus	WA97013A	WA97013A	2023-06-20
04042761083102	Olympus	WT218700		2023-06-20
04042761083119	Olympus	WT218705		2023-06-20
04042761083126	Olympus	WT218711		2023-06-20
04042761083133	Olympus	WT218720		2023-06-20
04042761083140	Olympus	WT630400		2023-06-20
04042761083164	Olympus	WT640021		2023-06-20
04042761083171	Olympus	WT645001	WT645001	2023-06-20
04042761083188	Olympus	WT645006	WT645006	2023-06-20
04042761083218	Olympus	WT645013	WT645013	2023-06-20
04042761083225	Olympus	WT645016	WT645016	2023-06-20
04042761083232	Olympus	WT645017	WT645017	2023-06-20
04042761083256	Olympus	WT645020	WT645020	2023-06-20
04042761083263	Olympus	WT645025	WT645025	2023-06-20
04042761083270	Olympus	WT645030	WT645030	2023-06-20
04042761083287	Olympus	WT645031	WT645031	2023-06-20

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
15711055100400	M-Drain	Mermaid Medical A/S	FGE	2024-10-01
15711055110041	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055110409	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055120040	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055120453	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055000311	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000328	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000359	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000373	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000410	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000434	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000458	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000472	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000496	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000519	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000533	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000557	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000588	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000595	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000625	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000632	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000663	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000670	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000700	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000724	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000748	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000762	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000779	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000809	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000816	M-Drain	Mermaid Medical A/S	FGE	2016-09-24

Olympus

Related Records#

Contact Domains#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Contacts#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#