Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1064584

FEI Number

3003063934

Entity Name

DEMETECH CORP.

City/State/Country

Miami Lakes, FL, US

Establishment Address

5980 Miami Lakes Drive, Miami Lakes, FL 33014, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DEMETECH CORP. (Owner Number: 9041973)

Owner / Operator Contact Address

5980 Miami Lakes Drive, --, Miami Lakes, FL 33014, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123940

PMA Number

N/A

All Registered Proprietary Names

DemeTECH PTFE-Polytetrafluoroethylene Nonabsorbable Suture Spigot Guard - Urine Collection Bag Drain Cap DemeCRYL DemeSORB DemeDIOX Barbed DemeDIOX DemeTECH Polydioxnone Synthetic Monofilament (PDO) Suture DemeGUT Chromic DemeGUT DemeGUT Plain Demetech Chromic Catgut Suture Demetech Plain Catgut Suture HemiGard Adhesive Suture Retention Device SutureGard Suture Retention Device DemeLON DemeSILK DemeSTEEL DemeCAPRONE DemeTUBE PRF DemeLENE Mesh DemeMASK N95 Respirator DemeMASK DemeQUICK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2018-11-06
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2023-11-14
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2025-04-21
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2002-05-07
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2019-12-09
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2011-02-01
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2008-05-01
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2020-02-06
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2003-04-10
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2002-05-07
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2022-08-02
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2014-11-10
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2023-11-14
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2014-01-22
GLE	Mixer, Blood Tube	Clinical Chemistry	Class 1	862.2050	2024-05-10
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2017-05-24
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-01
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2014-11-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEMETECH CORP.

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
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0014-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1064584. Last updated year: 2026. Please use registration number 1064584 when referencing this establishment in official correspondence.