Ansell Sandel Medical Solutions LLC

FDA Device Registration & Listing · CHATSWORTH, CA, US · Registration 3004125670

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004125670
FEI Number
3004125670
Entity Name
Ansell Sandel Medical Solutions LLC
City/State/Country
CHATSWORTH, CA, US
Establishment Address
9301 Oakdale Ave Ste 300, CHATSWORTH, CA 91311, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ANSELL HEALTHCARE PRODUCTS LLC (Owner Number: 8020065)
Owner / Operator Contact Address
2301 Robb Drive, Reno, NV 89523, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Gammex Silver Barrier Dressing KIT TURNOVER STAT-PAC STAT-BLOC™ Premium, Antimicrobial, Wide Table Sheet (90") w/ Elastic Edging at Head and Foot STAT-STRAP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2013-08-31
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2021-05-28
FMR Device, Transfer, Patient, Manual General Hospital Class 1 880.6785 2011-08-25
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2013-12-20
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-09-25
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2016-04-13
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2011-08-26
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2011-08-26
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2013-01-09
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2011-08-26
FMQ Restraint, Protective General Hospital Class 1 880.6760 2021-02-12

Official Correspondent

Don Cronk

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ANSELL HEALTHCARE PRODUCTS LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9610406 ANSELL (THAILAND) LTD. THAILAND Krung Thep Maha Nakhon, TH
3010459874 Ansell Perry de Mexico S.A. de C.V. Cd. Juarez Chihuahua, MX
3009964047 ANSELL HEALTHCARE PRODUCTS LLC Iselin, NJ, US
3003199637 Ansell Canada Inc. Cowansville Quebec, CA
8043736 ANSELL N.P. SDN. BHD. MELAKA, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K831798 I M, Inc. DISPOSABLE SCALPELS 1983-07-19
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K962327 Sekure Seat Corp. SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE 1997-03-06
K963243 Heelbo, Inc. HEELBO BLAZER SLEEVED JACKET 1996-10-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004125670. Last updated year: 2026. Please use registration number 3004125670 when referencing this establishment in official correspondence.
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