FDA.reportPublic FDA data

StitchKit

Primary DI
00860088000237
Brand
StitchKit
Company
ORIGAMI SURGICAL LLC
Model
VH-PC
Device description
StitchKit® PTFE Suture and Needle Management Device
Published
2023-03-28
Public version status
Update
Distribution status
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
NAYSystem,Surgical,Computer Controlled Instrument
NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
NAYSystem, Surgical, Computer Controlled InstrumentGastroenterology, Urology2
NBYSuture, Surgical, Nonabsorbable, Expanded, PolytetraflouroethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123811000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123811000STITCHKITOrigami Surgical, LLC2013-09-05NBY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860088000234PackageGS16In Commercial Distribution
00860088000237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086008800023410860088000234
00860088000237008600880002378600880002370860088000237

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9737656256info@origamisurgical.com

Regulatory Flags#

DUNS number
079994267
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004977377StitchKitSK-1092024-02-14
00860004977384StitchKitSK-1102024-02-14
00860004977322StitchKitSK-1082024-02-14
10860004977374StitchKitSK-1092024-02-14
10860004977381StitchKitSK-1102024-02-14
00860004977346StitchKitSK-1062023-03-28
00860004977308StitchKitSK-1032023-03-28
00860004977315StitchKitSK-1042023-03-28
10860004977305StitchKitSK-1032023-03-28
10860004977312StitchKitSK-1042023-03-28
00860004977339StitchKitSK-1052023-03-28
00860004977353StitchKitSK-1072023-03-28
00860088000206StitchKitSK-0022015-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
B382SD13768130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD30109760Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093838ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-07-29
00198506092435ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28