FDA.reportPublic FDA data

ProdiGI

Primary DI
20884521808383
Brand
ProdiGI
Company
Covidien LP
Model
ERD-TWSG
Catalog number
ERD-TWSG
Device description
Grasper, ERD-TWSG, Secondary Grasper
Published
2020-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDOApplier, surgical, clip
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521808383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452180838320884521808383

GMDN Terms#

Term, Definition table
TermDefinition
Internally-anchored endoscopic retractorA sterile, nonimplantable, intraoperative surgical instrument designed to be inserted into the abdominal or thoracic cavity through a compatible endoscopic instrument (e.g., an access port) to provide hands-free retraction of a selected organ by anchoring it to the cavity wall during a surgical intervention (e.g., gastroenterological, gynaecological and urological laparoscopic or thoracoscopic procedures). It is inserted using a dedicated applier and typically consists of two interconnected clips that clutch the tissue for anchoring to the cavity wall and grasping the organ. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521141117WarmTouch50308902019-02-06
10884521205024Shiley4CN65R2016-09-24
10884521205420Shiley5CN70R2016-09-24
10884521205437Shiley6CN75R2016-09-24
10884521205444Shiley7CN80R2016-09-24
10884521205451Shiley8CN85R2016-09-24
10884521205468Shiley9CN90R2016-09-24
10884521205475Shiley10CN10R2016-09-24
10884521205482Shiley4UN65R2016-09-24
10884521205499Shiley5UN70R2016-09-24
10884521205505Shiley6UN75R2016-09-24
10884521205512Shiley7UN80R2016-09-24
10884521205529Shiley8UN85R2016-09-24
10884521205536Shiley9UN90R2016-09-24
10884521205543Shiley10UN10R2016-09-24
10884521815360NellcorMAXFAST2021-08-09
10884521815469NellcorMAXFASTI2021-08-09
10884521820890Mon-a-Therm900412023-05-29
10884521820906Mon-a-Therm900422023-05-29
10884521820913Mon-a-Therm900432023-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04717480902064InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902101InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902118InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902149InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902170InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902217InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902293InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
08800042706111Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042706128Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042706135Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042706142Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042700065Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700904Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700911Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700928Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701369Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701376Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701390Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701406Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702878Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702885Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702892Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702908Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702915Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702922Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08809756910081Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
08809756910104Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
10381780540595CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
10381780540601CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
08809756910074Artisential Clip Applier LargeLIVSMEDGDO2025-09-08