Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016096140

FEI Number

3016096140

Entity Name

SIDMAN INDUSTRIES

City/State/Country

SHAHJAHANPUR, ALWAR Rajasthan, IN

Establishment Address

H-142, SHAHJAHANPUR INDUSTRIAL AREA, SHAHJAHANPUR, ALWAR Rajasthan 301706, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIDMAN INDUSTRIES (Owner Number: 10095398)

Owner / Operator Contact Address

H-142, SHAHJAHANPUR INDUSTRIAL AREA, SHAHJAHANPUR, ALWAR, IN-RJ 301706, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cyclothera Negative Pressure Wound Therapy System with Multifluid Instillation Vacuport Dynamic Incision Management System Incicare Incision NPWT CCNPWT Negative Pressure Wound Therapy Kit Insticare NPWT Instillation Dressing Kit CCNPWT BVL Filter InciCare Skin Stapler CCNPWT Canister CCNPWT Negative Pressure Wound Therapy System Cycloflo Negative Pressure Wound Therapy Kit Clean Heal CMF Fixation Systems Clean Heal Blood Lines Clean Heal IV Set Clean Heal Procedure Packs Clean Heal Hydrocolloid Dressing Sterile Dressing Pack Clean Heal Gauze / Sponge (X-ray Detectable) Clean Heal Silicon Dressing Clean Heal No Sting Barrier Dressing Permesorb Silver Dressing Permesorb IV Dressing Permederm Dressing Permesorb IV Cannula Fixation Dressing with 2% Chlorhexidine Gel Pad Permederm IO Drape Permederm Drape Permesorb Surgical Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PYL	Wound Drainage Kit	General, Plastic Surgery	Class 1	878.4014	2026-03-09
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2026-03-09
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2026-03-09

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

SIDMAN INDUSTRIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

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3004111573	Sterigenics US LLC	Grand Prairie, TX, US
3009888344	Isomedix Operations Inc	El Paso, TX, US
1643817	ISOMEDIX OPERATIONS INC	EL PASO, TX, US
3007329020	Cardinal Health 200, LLC	El Paso, TX, US
1526711	ISOMEDIX OPERATIONS INC	GROVEPORT, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016096140. Last updated year: 2026. Please use registration number 3016096140 when referencing this establishment in official correspondence.