Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005160949

FEI Number

3005160949

Entity Name

ARMOR PLAST LTD

City/State/Country

Bangalore Karnataka, IN

Establishment Address

235 B Bommasandra Industrial Area, Bangalore Karnataka 560099, IN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Adroit USA Inc (Owner Number: 10037845)

Owner / Operator Contact Address

1043 Serpentine Lane, Suite A, Pleasanton, CA 94566, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

situate Verisphere SCS Handle Sub Assembly Entrada 2 Sub Assembly SCS Tunneller Components UltraCor Twirl Needle TCN-Case & CSK-Case Sub Assemblies DBS Counterweight Vercise System Tension Guide Sub Assembly situate Verisphere Fixate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2019-07-18
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2019-06-20
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-06-20
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2019-06-20
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2019-06-20
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Unknown	Class 3	N/A	2019-06-20
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Unknown	Class 3	N/A	2019-06-20
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Unknown	Class 3	N/A	2019-06-20
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2019-07-18
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2026-03-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2026-03-10

Official Correspondent

Arpan Bajaj

US Agent Details

Arpan Bajaj Business: Adroit USA Inc Email: arpan@adroitusa.net Phone: (510) 2991796

Related Public Records

Same Entity

Adroit USA Inc

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015924373	AUSA Medical Device Pvt Ltd	Bangalore Karnataka, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020354	Baylis Medical Co., Inc.	BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)	2002-05-03
K201610	ABBOTT MEDICAL	IonicRF Generator	2020-10-21
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16
K242841	ABBOTT MEDICAL	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	2025-05-27
K190960	Boston Scientific Neuromodulation	Nalu Lead Blank (50cm)	2019-07-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2358-2024	Abbott Medical	3	Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

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3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
3035642068	Honduras Kitting, S.A.	Villanueva Cortes, HN
8010177	STRYKER LEIBINGER GMBH & CO. KG	FREIBURG Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005160949. Last updated year: 2026. Please use registration number 3005160949 when referencing this establishment in official correspondence.