DEVICE: StitchKit (00860088000206)
Device Identifier (DI) Information
StitchKit
SK-002
In Commercial Distribution
ORIGAMI SURGICAL LLC
SK-002
In Commercial Distribution
ORIGAMI SURGICAL LLC
StitchKit ePTFE Suture Delivery Canister
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
17467 | Polytetrafluoroethylene suture |
A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of expanded polytetrafluoroethylene (ePTFE) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread, used most frequently in cardiovascular surgery, provides temporary wound support until the wound sufficiently heals to withstand normal stress. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NAY | System,Surgical,Computer Controlled Instrument |
GCJ | Laparoscope, General & Plastic Surgery |
NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123811 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4e2efc2a-6c51-4629-8754-39115cca344f
July 06, 2018
3
October 26, 2015
July 06, 2018
3
October 26, 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 |
---|---|---|---|---|---|
00860088000213 | 6 | 00860088000206 | In Commercial Distribution | Box |
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
[?]
9737656256
info@origamisurgical.com
info@origamisurgical.com