FDA Device Registration & Listing · Cuauhtemoc Chihuahua, MX · Registration 3009750712
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 1994-02-02 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2007-04-26 |
| HMT | Drape, Patient, Ophthalmic | General, Plastic Surgery | Class 2 | 878.4370 | 2016-04-14 |
| EYX | Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-11 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2005-04-13 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2006-04-11 |
| PYC | Paracentesis Tray | General, Plastic Surgery | Class 1 | 878.4200 | 2018-07-02 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2018-07-27 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2018-07-27 |
| FYC | Gown, Isolation, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2016-07-29 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2015-06-02 |
| GAZ | Tubing, Noninvasive | General Hospital | Class 2 | 880.6740 | 2007-04-26 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2022-07-20 |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | General Hospital | Class 2 | 880.5570 | 2018-06-06 |
| ERY | Drape, Surgical, Ent | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-07 |
| OFA | Cardiovascular Surgical Instruments Tray | Cardiovascular | Class 1 | 870.4500 | 2009-05-07 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2023-02-01 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2023-02-02 |
| EYY | Drape, Urological, Disposable | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-11 |
| BYZ | Trap, Sterile Specimen | General Hospital | Class 2 | 880.6740 | 2021-06-25 |
| DRC | Trocar | Cardiovascular | Class 2 | 870.1390 | 2007-04-26 |
| HHK | Curette, Suction, Endometrial (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1175 | 2008-06-11 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2009-05-06 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2007-04-20 |
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-08 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2008-04-15 |
| KGW | Ring (Wound Protector), Drape Retention, Internal | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-11 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2006-04-11 |
| KGY | Bag, Intestine | General, Plastic Surgery | Class 1 | 878.4100 | 2017-03-17 |
No official correspondent registered.
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004839227 | Cardinal Health Malta 212 Ltd | Marsa, MT |
| 3015541720 | Cardinal Health Germany Manufacturing GmbH | Halberstadt Saxony-Anhalt, DE |
| 1033903 | Cardinal Health | Greenwood, SC, US |
| 9611018 | Cardinal Health Ireland Manufacturing Limited | TULLAMORE Offaly, IE |
| 8040459 | Kendall-Gammatron Limited | SAMPRAN Nakhon Pathom, TH |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K831798 | I M, Inc. | DISPOSABLE SCALPELS | 1983-07-19 |
| K781371 | Ferris Mfg. Corp. | BONE MARROW ASPIRATION KIT | 1978-09-20 |
| K892118 | Paramount Products, Inc. | NON-STERILE MASKS AND CAPS | 1989-04-20 |
| K961683 | J.J. Skinner, Inc. | JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY | 1996-05-10 |
| K910471 | Baxter Healthcare Corp | MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE | 1991-03-08 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0007-2013 | Invuity, Inc. | 2 | BriteField illuminated Suction Device;
Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray.
The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source. |
| Z-0017-2023 | Hobbs Medical, Inc. | 1 | Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe
Catalog Number: 4620 |
| Z-0018-2023 | Hobbs Medical, Inc. | 1 | Hobbs Transbronchial Aspiration Needle
Catalog Number: 4621 |
| Z-0023-2011 | Becton Dickinson & Company | 1 | BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106.
Needles are intended for use in aspiration and injection of medications. |
| Z-0027-2025 | Windstone Medical Packaging, Inc. | 2 | Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1043646 | Medegen Medical Products | GALLAWAY, TN, US |
| 3013298431 | VEENAK INTERNATIONAL LIMITED | BIRMINGHAM, GB |
| 3002834291 | MIAN SHAHID CORP. | MUZAFFAR PUR, SIALKOT Punjab, PK |
| 1820334 | Cook Incorporated | Bloomington, IN, US |
| 3006859759 | XIAN KAYDEE MEDICAL APPLIANCES CO., LTD. | xian Shaanxi, CN |
3009750712 when referencing this establishment in official correspondence.