FDA.reportPublic FDA data

JustRight 5mm Retrieval bag, 125ml

Primary DI
00850346007016
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
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
Lot or batch
true
Expiration date on label
true
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
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
10850346007013JustRight 5mm Retrieval bag, 125mlJR-125 ECO-10JR-125 ECO-102016-11-18

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