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Intra-Knot®

FDA UDI

Class I (US FDA UDI)

by LSI Solutions, Inc.

Identity

Trade Name
INTRA-KNOT® FDA UDI
Generic Name
Suture clasp, non-bioabsorbable FDA UDI
Device Name
INTRA-KNOT® QUICK LOAD® UNIT FDA UDI
Model / Reference
032040 FDA UDI
Description
INTRA-KNOT® QUICK LOAD® UNIT FDA UDI

Identifiers

Catalog Number
032040 FDA UDI
Primary DI / UDI-DI
00850200006285 FDA UDI
510(k) Number
K100593 FDA UDI
FDA Product Code
HCF FDA UDI
GMDN Term
Suture clasp, non-bioabsorbable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 40 Centimeter FDA UDI

Category: Suture clasp, non-bioabsorbable

Intra-Knot® by LSI Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suture clasp, non-bioabsorbable.

Cleared under the same submission

K100593 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
LSI Solutions, Inc.

Sources (1)

  • FDA UDI 35194fe6-11af-44d9-b7af-5182acffa324 37 fields · synced May 30, 2026