Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015414875

FEI Number

3015414875

Entity Name

JACK JACK LLC

City/State/Country

Miami, FL, US

Establishment Address

382 NE 191st St, PMB 33423, Miami, FL 33179, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

JACK JACK LLC (Owner Number: 10059740)

Owner / Operator Contact Address

382 NE 191st St, PMB 33423, Miami, FL 33179, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Honey Calcium Alginate Dressing Silicone Foam Dressing Adhesive Island Dressing Silicone Scar Sheets Hydrocolloid Dressing Patient Turning Device Sterile Gauze Pad Sterile Gauze Sponges Heat Patch for Menstrual, Heat Wraps for Cramps, Heat Patch Muscle Pain Therapy Silicone Scar Gel Stockinette, Cover Limb, Tubular Bandage JJ CARE Temporary Tooth Cement, Zinc Eugenol Powder & Liquid, Eugenol Cement, Zinc Oxide Eugenol Callus Cushion Gauze Roll Umbilical Hernia Belt Waterproof Adhesive Island Dressing Alginate Dressing Adhesive Island Dressing Aligner Cleaner Ostomy Barrier Strips Ostomy Barrier Rings

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-07-06
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2020-07-05
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2024-12-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-08-26
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-01-22
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2020-07-05
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2023-02-13
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2024-01-22
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2024-12-06
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2021-07-16
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2024-12-06
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-04-28
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2024-12-06
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2024-01-22
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-07-06

Official Correspondent

SUNGWOO CHO

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

JACK JACK LLC

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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015414875. Last updated year: 2026. Please use registration number 3015414875 when referencing this establishment in official correspondence.