Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044030

FEI Number

3009995358

Entity Name

JAI SURGICALS LTD.

City/State/Country

ALWAR Rajasthan, IN

Establishment Address

SP 146 (L) RIICO INDUSTRIAL AREA, BHIWADI, ALWAR Rajasthan 301019, IN

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

JAI SURGICALS LTD. (Owner Number: 9005214)

Owner / Operator Contact Address

B-3 INFOCITY, SECTOR 33-34, --, GURGAON, HARYANA, IN-NOTA 122001, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	1987-04-20
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1995-06-23
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2006-03-23
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-03-23
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	1991-12-18

Official Correspondent

SANJIV KEHR

US Agent Details

Abul Q. Ansari Email: aqansari31@gmail.com Phone: (603) 2030935

Related Public Records

Same Entity

JAI SURGICALS LTD.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.

Similar Registrations

Registration Number	Establishment Name	Location
3040389290	HUAIYIN MEDICAL INSTRUMENTS CO., LTD.	Huai an City Jiangsu, CN
3014649053	Sterilance Medical (Suzhou) Inc.	Suzhou Jiangsu, CN
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, IL, US
3016844398	AG MARKETING & DEVELOPMENT GROUP INC DBA AGMD GROUP	Brampton Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044030. Last updated year: 2026. Please use registration number 8044030 when referencing this establishment in official correspondence.