Roth Net 00711152

GUDID 10724995182691

The disposable Roth Net foreign body enteroscope retrieval device is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.

US Endoscopy

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Primary Device ID	10724995182691
NIH Device Record Key	f4fc1d95-4ec4-45eb-8182-942af0cf77e3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Roth Net
Version Model Number	00711152
Catalog Number	00711152
Company DUNS	627879687
Company Name	US Endoscopy
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx

Device Dimensions

Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter
Outer Diameter	2.5 Millimeter
Length	350 Centimeter
Width	3 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995182694 [Primary]
GS1	00816765011263 [Previous]
GS1	10724995182691 [Package] Contains: 00724995182694 Package: Case [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K122462

FDA Product Code

GCJ	Laparoscope, general & plastic surgery

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-03-27
Device Publish Date	2020-03-19

On-Brand Devices [Roth Net]

10816765013516	The Roth Net retriever is used to retrieve excised polyps, tissue samples, foreign bodies and ca
10816765013509	The Roth Net retriever select is used to retrieve excised polyps, tissue samples, foreign bodies
10816765012854	The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samp
10816765012717	The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samp
10816765012601	The Roth Net foreign body mini retriever product line is intended to be used to retrieve excised
10816765011291	The Roth Net foreign body maxi is used in the endoscopic retrieval of foreign bodies and excised
10816765011284	The Roth Net foreign body standard is used in the endoscopic retrieval of foreign bodies and exc
10816765011260	The disposable Roth Net foreign body enteroscope retrieval device is used in the endoscopic retr
10816765011253	The disposable Roth Net polyp retrieval device is used in the endoscopic retrieval of foreign bo
10816765011246	The disposable Roth Net polyp retrieval device is used in the endoscopic retrieval of foreign bo
10816765010904	The disposable Roth Net foreign body maxi retrieval device is used in the endoscopic retrieval o
10816765010898	The disposable Roth Net foreign body mini retrieval device is used in the endoscopic retrieval o
10816765010881	The disposable Roth Net foreign body standard retrieval device is used in the endoscopic retriev
10816765010874	The disposable Roth Net foreign body standard retrieval device is used in the endoscopic retriev
10816765010867	The disposable Roth Net foreign body standard retrieval device is used in the endoscopic retriev
10816765013653	The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, tissu
10816765013646	The Roth Net retriever 360 product line is intended to be used to retrieve excised polyps, tissu
10724995182868	The Roth Net retriever 360 product line is intended to be used to retrieve excised polyps, tissu
10724995182851	The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, tissu
10724995182776	The Roth Net retriever is used to retrieve excised polyps, tissue samples, foreign bodies and ca
10724995182769	The Roth Net retriever select is used to retrieve excised polyps, tissue samples, foreign bodies
10724995182752	The Roth Net foreign body mini retriever product line is intended to be used to retrieve excised
10724995182745	The Roth Net foreign body maxi is used in the endoscopic retrieval of foreign bodies and excised
10724995182738	The Roth Net foreign body standard is used in the endoscopic retrieval of foreign bodies and exc
10724995182721	The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samp
10724995182714	The Roth Net retriever mini polyp is intended to be used to retrieve excised polyps, tissue samp
10724995182691	The disposable Roth Net foreign body enteroscope retrieval device is used in the endoscopic retr
10724995182684	The disposable Roth Net polyp retrieval device is used in the endoscopic retrieval of foreign bo
10724995182677	The disposable Roth Net polyp retrieval device is used in the endoscopic retrieval of foreign bo
10724995182530	The disposable Roth Net foreign body maxi retrieval device is used in the endoscopic retrieval o
10724995182523	The disposable Roth Net foreign body mini retrieval device is used in the endoscopic retrieval o
10724995182516	The disposable Roth Net foreign body standard retrieval device is used in the endoscopic retriev
10724995182509	The disposable Roth Net foreign body standard retrieval device is used in the endoscopic retriev
10724995182493	The disposable Roth Net foreign body standard retrieval device is used in the endoscopic retriev

Trademark Results [Roth Net]

Mark Image Registration \| Serial	Company Trademark Application Date
ROTH NET 76602566 3008369 Live/Registered	U.S. Endoscopy Group, Inc. 2004-07-16