DEVICE: JustRight 5mm Stapler (00865163000102)
Device Identifier (DI) Information
JustRight 5mm Stapler
JR-ST25-2.0
In Commercial Distribution
JR-ST25-2.0
JUSTRIGHT SURGICAL, LLC
JR-ST25-2.0
In Commercial Distribution
JR-ST25-2.0
JUSTRIGHT SURGICAL, LLC
JustRight 5mm Stapler-single
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35615 | Surgical staple loading unit, non-cutting |
A 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.
|
Active | true |
59871 | Endoscopic manual linear cutting stapler, single-use |
A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecologic, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses; it may also be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAG | STAPLER, SURGICAL |
GDW | STAPLE, IMPLANTABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K132472 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Shaft diameter 5 mm |
Device Size Text, specify: Staple height 2 mm |
Device Record Status
ed8c4232-8539-422f-a89b-915988a2b740
April 20, 2023
7
August 10, 2015
April 20, 2023
7
August 10, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10865163000109 | 6 | 00865163000102 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)442-9892
customersupport@hologic.com
customersupport@hologic.com