Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042940336

FEI Number

3042940336

Entity Name

COBA BIOMEDICAL PTY (LTD)

City/State/Country

Bloemfontein Free State, ZA

Establishment Address

Unit 16, Eland Industrial Park 42, Eland Street, Qwaggafontein, Bloemfontein Free State 9301, ZA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Coba Biomedical PTY (Ltd) (Owner Number: 10094558)

Owner / Operator Contact Address

Unit 16, Eland Industrial Park 42, Eland Street, Qwaggafontein, Bloemfontein, ZA-FS 9301, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LiFT Light Retractor Bone trap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2026-06-02
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-12-09
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2026-06-02
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2026-06-02
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2026-06-02
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-06-02
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-06-02
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2026-03-26
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-06-02
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-06-02
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2026-06-02
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-06-02
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-06-02
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2026-06-02
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2026-03-26
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-06-02
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-06-02
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-06-02
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-06-02
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2026-06-02
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-06-02
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-06-02
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-06-02
HTX	Rongeur	Orthopedic	Class 1	888.4540	2025-12-09
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-06-02
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2025-12-09

Official Correspondent

William Kinnear

US Agent Details

Kim Hernandez Business: Wexler Surgical INC. Email: Kim.AHernandez@WexlerSurgical.com Phone: (713) 7236900

Related Public Records

Same Entity

Coba Biomedical PTY (Ltd)

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K871646	Ocular Instruments, Inc.	TANNE CORNEAL CUTTING BLOCK	1987-05-18
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
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-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042940336. Last updated year: 2026. Please use registration number 3042940336 when referencing this establishment in official correspondence.