FDA.reportPublic FDA data

Roth Net

Primary DI
00724995182519
Brand
Roth Net
Company
US Endoscopy
Model
00711053
Catalog number
00711053
Device description
The disposable Roth Net foreign body standard retrieval device is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.
Published
2020-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDISNARE, FLEXIBLE
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122462000
K182909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122462000ROTH NET RETRIEVERUnited States Endoscopy Group, Inc.2012-09-11FDI
K182909000Roth Net Retriever Product LineUnited States Endoscopy Group, Inc.2018-11-21FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995182516PackageGS15In Commercial Distribution
00816765010884PreviousGS10
00724995182519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518251610724995182516
00816765010884008167650108848167650108840816765010884
00724995182519007249951825197249951825190724995182519

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/airway foreign body retrieval basket, single-useA flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). It is typically designed with a long, thin, flexible body that has an expandable basket at the distal end in which objects are caught for extraction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Contacts#

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

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 table
Primary DIBrandModelCatalogPublished
10724995184015Endo-Boot00711621007116212020-04-01
10724995184022Endo-Boot00711622007116222020-04-01
00724995190637ProArmor00711623007116232020-07-16
00724995190644ProArmor00711624007116242020-07-16
00724995180355NA3905133905132020-04-02
00724995180362CO2MPACT7103007103002020-04-02
00724995180386NA7103047103042020-04-02
00724995180409NA7104247104242020-04-02
00724995180416NA7104257104252020-04-02
00724995180423NA7104267104262020-04-02
00724995180430NA7106027106022020-04-02
00724995180447NA7106037106032020-04-02
00724995180454NA7106047106042020-04-02
00724995180522Torrent00711579007115792020-04-01
00724995180768UltramatrixUSBOLUSBOL2020-04-02
00724995180775UltramatrixUSBORUSBOR2020-04-02
00724995180782iSnare00711084007110842020-03-19
00724995180843Articulator00711804007118042020-04-01
00724995182472Short Throw00711018007110182020-03-19
00724995182489Short Throw00711019007110192020-03-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
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00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
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00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
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00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776432911MillenniumAvalign Technologies, Inc.GCJ2026-09-30
00190776432928MillenniumAvalign Technologies, Inc.GCJ2026-09-30