Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012660022

FEI Number

3012660022

Entity Name

SDP INC.

City/State/Country

Saint-Laurent Quebec, CA

Establishment Address

7925 Henri-Bourassa West, Saint-Laurent Quebec H4S 1P7, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SDP Inc. (Owner Number: 10052289)

Owner / Operator Contact Address

7925 Henri-Bourassa West, Saint-Laurent, CA-QC H4S 1P7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SDP TRACTION ROPE SDP ELASTIC BAND SDP ROUND SPONGE SDP GAUZE PACKING SDP GAUZE SPONGE SDP NEUROLOGICAL STRIP SDP PACKING STRIP SDP LAPAROTOMY SPONGE SDP COTTON BALL SPD PEANUT SPONGE SDP ENT PACKING SDP CYLINDRICAL SPONGE SDP NASAL PACKING SDP NASAL SPONGE SDP VAGINAL PACKING SDP TONSIL SPONGE SDP GAUZE SDP STICK SPONGE SDP THROAT PACKING SDP NEUROLOGICAL SPONGE SDP DENTAL PACKING SDP APPLICATOR STICKS SDP TONGUE DEPRESSOR SDP APPLICATOR SWAB SDP TOOTH PICKS POINTED END SDP SPECIAL WOODEN STICK SDP COTTON TIP APPLICATOR SDP CONTRAST BACKGROUND MATERIAL SDP DISSECTOR SPONGE SDP KITTNER DISSECTOR SPONGE SDP COTTON TAPE UMBILICAL SDP STRETCH BANDAGE SDP GAUZE NON WOVEN SDP STOCKINETTE SDP TENSOR BANDAGE SDP GAUZE BANDAGE SDP PREP SCRUB SPONGE SDP HERNIA TAPE SDP MESH GAUZE SDP TWILL TAPE SDP CAST PADDING SDP FLANNEL ROLL SDP GAUZE DRESSING SDP TRACHEOSTOMY SPONGE SDP VAGINAL PACKING SDP STICK SPONGE SDP NASAL PACKING SDP CYLINDRICAL ROLL SDP COTTON BALL SDP CYLINDRICAL SPONGE SDP THROAT PACKING SDP DENTAL SPONGE SDP ENT PACKING SDP FLUFF BANDAGE SDP GAUZE SDP FLUFF GAUZE SDP GAUZE SPONGE SDP ROUND SPONGE SDP GAUZE PACKING SDP COTTON ROLL SDP NASAL PLUGS SDP DENTAL PACKING SDP COTTON PAD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	2023-06-28
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2016-07-18
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2016-07-15
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2016-07-18
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2016-07-13
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2025-08-04
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-07-14
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2022-05-04
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-07-18
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2016-07-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-07-18
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2016-07-18
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2016-07-15

Official Correspondent

No official correspondent registered.

US Agent Details

Raj Mehta Email: rajiv.mehta@sdpmedical.com Phone: (646) 6236480

Related Public Records

Same Entity

SDP Inc.

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012660022. Last updated year: 2026. Please use registration number 3012660022 when referencing this establishment in official correspondence.