Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006065092

FEI Number

3006065092

Entity Name

G Surgiwear Limited

City/State/Country

Shahjahanpur Uttar Pradesh, IN

Establishment Address

Village Hathoda Buzurg, Shahjahanpur Uttar Pradesh 242001, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

G Surgiwear Limited (Owner Number: 10092164)

Owner / Operator Contact Address

Rasoolpur Jahanganj near Hathoda Chauraha, Sadar, Shahajahanpur, IN-UP 242001, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EMQUET (EmRescue) COMPACT PORTABLE EMERGENCY STRETCHER (EmRescue) CPR Mask (EmRescue) UEM SPLINT (EmRescue) EMCOM 3'' & 4'' (EmRescue) THOLOK Chest seal (EmRescue) EMCOM CHEST/ ABDOMEN (EmRescue) RAKSHIKA (ISLY) (EmRescue) GAUZE PAD (EmRescue) NETRA KAVACH (EmRescue)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2024-12-11
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2024-12-11
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2024-12-11
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2024-12-11
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-12-11
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-12-11
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-12-11

Official Correspondent

Dr. Ghanshyam Das Agrawal

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (570) 1516482

Related Public Records

Same Entity

G Surgiwear Limited

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
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006065092. Last updated year: 2026. Please use registration number 3006065092 when referencing this establishment in official correspondence.