FDA.reportPublic FDA data

Halyard

Primary DI
10809160472033
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
NMBP44-01
Catalog number
NMBP44-01
Published
2025-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCHTRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCHTray, Biopsy, Without Biopsy InstrumentsGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160472030PackageGS130In Commercial Distribution
10809160472033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916047203020809160472030
1080916047203310809160472033

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160532676HalyardMSBS14-05_0006MSBS14-052026-09-04
10809160532683HalyardMSTK53-06_0002MSTK53-062026-09-04
10809160532690HalyardMSCS51-06_0005MSCS51-062026-09-04
10809160532706HalyardSFSBPAR65-02_0003SFSBPAR65-022026-09-04
10809160532713HalyardBPAR65-02_0002BPAR65-022026-09-04
10809160532737HalyardFBCH103-07_0015FBCH103-072026-09-04
10809160532744HalyardMSTK53-07_0001MSTK53-072026-09-04
10809160532768HalyardBKAP27-03_0006BKAP27-032026-09-04
10809160532775HalyardEURO053-02_0003EURO053-022026-09-04
10809160532782HalyardKAFB008-10_0016KAFB008-102026-09-04
10809160532799HalyardWRNM019-16_0003WRNM019-162026-09-04
10809160532805HalyardNAMC436-13_0007NAMC436-132026-09-04
10809160532812HalyardNAMC433-07_0008NAMC433-072026-09-04
10809160532829HalyardWRNM025-12_0005WRNM025-122026-09-04
10809160532836HalyardEAMC1000-05AUX2_0002EAMC1000-05AUX22026-09-04
10809160532843HalyardWRNM007-18_0003WRNM007-182026-09-04
10809160532850HalyardNAMC474-06_0004NAMC474-062026-09-04
10809160532867HalyardBAAK106-15_0002BAAK106-152026-09-04
10809160532874HalyardKAFB009-16_0004KAFB009-162026-09-04
10809160532881HalyardFBCH130-04_0005FBCH130-042026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M78312011160Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-11-14
M78312011161Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-11-14
00810185250363TherapakTherapak LLCFCH2025-08-11
00810185250387TherapakTherapak LLCFCH2025-08-11
00810185250424TherapakTherapak LLCFCH2025-08-11
00810185250448TherapakTherapak LLCFCH2025-08-11
00810185250523TherapakTherapak LLCFCH2025-08-11
00810185250370TherapakTherapak LLCFCH2025-08-11
00810185250431TherapakTherapak LLCFCH2025-08-11
00810185250455TherapakTherapak LLCFCH2025-08-11
00810185250530TherapakTherapak LLCFCH2025-08-11
00810185250400TherapakTherapak LLCFCH2025-08-04
00810185250394TherapakTherapak LLCFCH2025-08-04
20809160472030HalyardAVID MEDICAL, INC.FCH2025-07-02
M78312011150Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-06-30
00191072239426ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2025-05-27
M78312011130Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-04-03
M78312011120Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-02-28
00191072236067ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2025-01-31
00191072236098ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2025-01-31
00191072233714ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-12-19
M78312011100Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-10-31
M78312011101Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-10-31
00191072231376ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-10-21
00191072230935ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-10-14
M78312011080Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-06-07
M78312011081Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-06-07
00191072223982ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-05-08
00191072223999ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-05-08
00191072223616ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-05-03