Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010280860

FEI Number

3010280860

Entity Name

SINA-STERILGAMMA SDN BHD

City/State/Country

Pelabuhan Klang Selangor, MY

Establishment Address

Lot 88077, Jalan Perigi Nenas 7/1, Taman Perindustrian, Pulau Indah, Pelabuhan Klang Selangor 42907, MY

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

SINA-SterilGamma Sdn Bhd (Owner Number: 10043035)

Owner / Operator Contact Address

Lot 88077, Jalan Perigi Nenas 7/1, Taman Perindustrian, Pulau Indah, Pelabuhan Klang, MY-10 42907, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shield, Protective, Personnel BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING Drape, Surgical ENTERAL FEEDING TUBE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2024-01-08
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2018-03-05
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2013-02-05
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-02-05
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2026-01-07
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2013-01-21
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2026-01-07
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-11-30
BSS	Tube, Nasogastric	Gastroenterology, Urology	Class 2	876.5980	2013-01-21

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

SINA-SterilGamma Sdn Bhd

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
K981334	Richard Wolf Medical Instruments Corp.	LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)	1998-09-10
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Similar Registrations

Registration Number	Establishment Name	Location
3022862651	SURGISCAPE	Sialkot Punjab, PK
3014334038	Integra LifeSciences Production Corporation	Mansfield, MA, US
3003418325	Integra LifeSciences Corporation	Princeton, NJ, US
9611262	WILLY STORZ GMBH	Rietheim-Weilheim Baden-Wurttemberg, DE
9613083	TOWNE BROTHERS (PVT.), LTD.	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010280860. Last updated year: 2026. Please use registration number 3010280860 when referencing this establishment in official correspondence.