Protégé™ GPS™

Primary DI: 00821684071519
Brand: Protégé™ GPS™
Company: EV3, INC
Model: SERB65-10-30-120
Device description: STENT SERB65-10-30-120 PROTEGE GPS V05
Published: 2015-09-01
Public version status: Update
Distribution status: Not in Commercial Distribution
MRI safety: MR Conditional
Rx: true
Sterile: true
Single use: true

Contact Domains#

medtronic.com

Product Codes#

Code, Name table
Code	Name
FGE	CATHETER, BILIARY, DIAGNOSTIC
NIO	STENT, ILIAC

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	2
NIO	Stent, Iliac	Unknown	3

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K021729	000
K033314	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K021729	000	MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY	Sulzer Intratherapeutics, Inc.	2002-06-21	FGE
K033314	000	PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM	Ev3, Inc.	2003-11-21	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00821684071519	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00821684071519	00821684071519	821684071519	0821684071519

GMDN Terms#

Term, Definition table
Term	Definition
Bare-metal biliary stent	A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes#

Type, Value, Unit table
Type	Value	Unit
Catheter Gauge	6	French
Length	30	Millimeter

Storage And Handling#

Type, Low, High table
Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Keep away from sunlight
Special Storage Condition, Specify	0	0	Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
Phone	Email
+1(800)633-8766	Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number: 117446916
Device count: 1
Lot or batch: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Published
00199150028399	Liberant™	LMT-TRX	2026-05-07
00821684071397	Protégé™ GPS™	SERB65-09-20-120	2015-09-04
00821684071403	Protégé™ GPS™	SERB65-09-20-80	2015-09-04
00821684071410	Protégé™ GPS™	SERB65-09-30-120	2015-09-04
00821684071427	Protégé™ GPS™	SERB65-09-30-80	2015-09-04
00821684071434	Protégé™ GPS™	SERB65-09-40-120	2015-09-04
00821684071441	Protégé™ GPS™	SERB65-09-40-80	2015-09-04
00821684071458	Protégé™ GPS™	SERB65-09-60-120	2015-09-04
00821684071465	Protégé™ GPS™	SERB65-09-60-80	2015-09-04
00821684071472	Protégé™ GPS™	SERB65-09-80-120	2015-09-04
00821684071489	Protégé™ GPS™	SERB65-09-80-80	2015-09-04
00821684071496	Protégé™ GPS™	SERB65-10-20-120	2015-09-01
00821684071502	Protégé™ GPS™	SERB65-10-20-80	2015-09-01
00821684071526	Protégé™ GPS™	SERB65-10-30-80	2015-09-01
00821684071533	Protégé™ GPS™	SERB65-10-40-120	2015-09-01
00821684071540	Protégé™ GPS™	SERB65-10-40-80	2015-09-01
00821684071557	Protégé™ GPS™	SERB65-10-60-120	2015-09-01
00821684071564	Protégé™ GPS™	SERB65-10-60-80	2015-09-01
00821684071571	Protégé™ GPS™	SERB65-10-80-120	2015-09-01
00821684071588	Protégé™ GPS™	SERB65-10-80-80	2015-09-01

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

Protégé™ GPS™

Related Records#

Contact Domains#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Device Sizes#

Storage And Handling#

Sterilization Methods#

Contacts#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#