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Instrument, Manual, Surgical, General Use

FDA UDI

Class I (US FDA UDI)

by Parcus Medical Llc

Identity

Trade Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE FDA UDI
Generic Name
Suture/ligature tightener, reusable FDA UDI
Device Name
Suture Pull Handle, Unsterile FDA UDI
Model / Reference
11362 FDA UDI
Description
Suture Pull Handle, Unsterile FDA UDI

Identifiers

Primary DI / UDI-DI
00816342025072 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
Suture/ligature tightener, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Suture/ligature tightener, reusable

Instrument, Manual, Surgical, General Use by Parcus Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suture/ligature tightener, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Parcus Medical Llc

Sources (1)

  • FDA UDI cab0ce72-3755-4fe5-836a-f899dde30340 33 fields · synced May 31, 2026