StitchKit

FDA UDI

Class II (US FDA UDI)

by Origami Surgical, LLC

Identity

Trade Name: StitchKit FDA UDI
Generic Name: Polyolefin/fluoropolymer suture, monofilament FDA UDI
Device Name: StitchKit® PTFE Suture and Needle Management Device FDA UDI
Model / Reference: VH-PC FDA UDI
Description: StitchKit® PTFE Suture and Needle Management Device FDA UDI

Identifiers

Primary DI / UDI-DI: 00860088000237 FDA UDI
510(k) Number: K123811 FDA UDI
FDA Product Code: NAY FDA UDI
GCJ FDA UDI
NBY FDA UDI
GMDN Term: Polyolefin/fluoropolymer suture, monofilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
878.5035 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Polyolefin/fluoropolymer suture, monofilament

StitchKit by Origami Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyolefin/fluoropolymer suture, monofilament.

SUTUMED — Unilene Sac · Class II
DemeLENE — DemeTECH Corp · Class II
DemeLENE — DemeTECH Corp · Class II
ATRAMAT — Internacional Farmacéutica S.A DE C.V · Class II
DemeLENE — DemeTECH Corp · Class II
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
Premilene — B BRAUN SURGICAL SA · Class II
DEKNATEL — TELEFLEX INCORPORATED · Class II

Cleared under the same submission

K123811 also covers:

StitchKit — Origami Surgical, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Origami Surgical, LLC

Sources (1)

FDA UDI 71f35a4c-8569-4915-87eb-64f336183ad9 35 fields · synced May 30, 2026