Reach

Primary DI: 10816765010638
Brand: Reach
Company: US Endoscopy
Model: 00712140
Catalog number: 00712140
Device description: Reach Overtube
Published: 2016-09-17
Public version status: Update
Distribution status: Not in Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: true

Related Records

Contact Domains

usendoscopy.com

Product Codes

Code	Name
FED	endoscopic access overtube, gastroenterology-urology

Product Code Classifications

Code	Device	Specialty	Class
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
10816765010638	Package	GS1	3	Not in Commercial Distribution
00816765010631	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
10816765010638	10816765010638
00816765010631	00816765010631	816765010631	0816765010631

GMDN Terms

Term	Definition
Endoscopic overtube, single-use	A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device.

Term

Definition

Endoscopic overtube, single-use

A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device.

Device Sizes

Type	Value	Unit
Outer Diameter	16.5	Millimeter

Storage And Handling

Type	Low	High	Condition
Storage Environment Temperature	15 Degrees Celsius	25 Degrees Celsius

Sterilization Methods

Method

Contacts

Phone	Email
+1(800)769-8226	global@usendoscopy.com

Regulatory Flags

DUNS number: 627879687
Device count: 1
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: true
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: true
Sterilization required before use: false

Other Devices From This Company

Primary DI	Brand	Model	Catalog	Published
00724995233327	Duoswift	00711600	00711600	2026-03-12
10724995362635	VIA	VIA Custom Procedure Kit	00717441	2026-03-06
10724995362642	VIA	VIA Custom Procedure Kit	00717442	2026-03-06
10724995362659	VIA	VIA Custom Procedure Kit	00717443	2026-03-06
10724995243750	Exacto Mundo	00711078	00711078	2025-08-19
10724995243767	Exacto Mundo	00711079	00711079	2025-08-19
10724995244535	Lumiflex	00733223	00733223	2025-08-19
00724995244545	Lumiflex	00715506W	00715506W	2025-06-03
00724995244552	Lumiflex	00715508W	00715508W	2025-06-03
00724995244569	Lumiflex	00715510W	00715510W	2025-06-03
00724995244576	Lumiflex	00715512W	00715512W	2025-06-03
00724995244583	Lumiflex	00715515W	00715515W	2025-06-03
00724995244590	Lumiflex	00715518W	00715518W	2025-06-03
00724995244606	Lumiflex	00715506	00715506	2025-06-03
00724995244613	Lumiflex	00715508	00715508	2025-06-03
00724995244620	Lumiflex	00715510	00715510	2025-06-03
00724995244637	Lumiflex	00715512	00715512	2025-06-03
00724995244644	Lumiflex	00715515	00715515	2025-06-03
00724995244651	Lumiflex	00715518	00715518	2025-06-03
00724995244668	Lumiflex	00718006W	00718006W	2025-06-03

Other Devices Sharing Product Codes

Primary DI	Brand	Company	Product code	Published
16925816667210	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-03-16
16925816667227	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-03-16
16925816667234	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-03-16
16970462547454	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547461	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547478	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547485	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547492	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547508	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547515	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547522	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547539	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547546	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547553	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547560	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547577	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547584	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547591	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547607	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16970462547614	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	FED	2026-02-10
16925816657518	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-01-26
16925816657525	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-01-26
16925816657532	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-01-26
16925816657549	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-01-26
16925816657556	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-01-26
16925816657563	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-01-26
16925816657570	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-01-26
16925816657587	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-01-26
16925816657594	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-01-26
16925816657600	ClearPetra	Well Lead Medical Co.,Ltd	FED	2026-01-26