FDA.reportPublic FDA data

JustRight 5mm Stapler

Primary DI
10865163000109
Brand
JustRight 5mm Stapler
Company
JUSTRIGHT SURGICAL, LLC
Model
JR-ST25-2.0
Catalog number
JR-ST25-2.0
Device description
JustRight 5mm Stapler-single
Published
2015-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAGSTAPLER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAGStapler, SurgicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132472000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132472000JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOADJustright Surgical, LLC2014-02-11GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10865163000109PackageGS16In Commercial Distribution
00865163000102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086516300010910865163000109
00865163000102008651630001028651630001020865163000102

GMDN Terms#

Term, Definition table
TermDefinition
Surgical staple loading unit, non-cuttingA unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)683-1743customersupport@justrightsurgical.com
+1(800)442-9892customersupport@hologic.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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479282852McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282883McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
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20612479282906McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282913McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282920McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282937McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282944McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283019McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283194McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283200McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283217McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283224McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283231McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283248McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283255McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284597McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284641McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284986McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285006McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285020McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285105McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
00190776409500MillenniumAvalign Technologies, Inc.GAG2025-09-02
10705036043522ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043539ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043546ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043529ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043536ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043543ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10888277368293MEDLINE RENEWALMEDLINE INDUSTRIES, INC.GAG2025-02-14