FDA.reportPublic FDA data

JustRight 5mm Retrieval bag, 125ml

Primary DI
10850346007013
Brand
JustRight 5mm Retrieval bag, 125ml
Company
JUSTRIGHT SURGICAL, LLC
Model
JR-125 ECO-10
Catalog number
JR-125 ECO-10
Device description
JustRight 5mm Retrieval bag, 125ml, 10 bags/case
Published
2016-11-18
Public version status
Update
Distribution status
Not 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
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111845000THE ESPINER SAC OR E SACEspiner Medical Limited2011-09-26GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850346007013PackageGS110Not in Commercial Distribution
00850346007016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085034600701310850346007013
00850346007016008503460070168503460070160850346007016

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)683-1743customersupport@justrightsurgical.com

Regulatory Flags#

DUNS number
025214641
Device count
1
DM exempt
true
Premarket exempt
false
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865163000102JustRight 5mm StaplerJR-ST25-2.0JR-ST25-2.02015-08-10
00865163000119JustRight5mm ReloadJR-REL25-2.0JR-REL25-2.02015-08-10
00850346007016JustRight 5mm Retrieval bag, 125mlJR-125 ECO-10JR-125 ECO-102016-11-18
00865163000126JustRight SealerJR-SE20JR-SE202015-08-10
00850346007023CoolSeal™ GeneratorCSL-200-50CSL-200-502020-10-13
00865163000133JustRight GeneratorJR100JR1002015-08-10
10850346007037CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
10850346007044CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
10850346007068CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
10850346007099CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
10865163000109JustRight 5mm StaplerJR-ST25-2.0JR-ST25-2.02015-08-10
10865163000116JustRight5mm ReloadJR-REL25-2.0JR-REL25-2.02015-08-10
10865163000123JustRight SealerJR-SE20JR-SE202015-08-10
10850346007006JustRight 5mm Retrieval bag, 60mlJR-60 ECO-10JR-60 ECO-102016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
07613327502800PinpointSTRYKER CORPORATIONGCJ2019-07-30
08806182216626LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182216657LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182210334LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210372LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210396LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210518LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210587LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210877LaportSejong Medical Co., LtdGCJ2018-04-05
07613327311839Connect OR OSSTRYKER CORPORATIONGCJ2017-06-30
07613327311846Connected OR OSSTRYKER CORPORATIONGCJ2017-06-30
08719324463126symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463133symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463140symphonX™Fortimedix Surgical B.V.GCJ2017-02-15