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
10809160528112HalyardSAMM041-08_0001SAMM041-082026-07-30
10809160528129HalyardNAMC434-09_0002NAMC434-092026-07-30
10809160528136HalyardNAFB062-09_0001NAFB062-092026-07-30
10809160528143HalyardGBEY17-02_0011GBEY17-022026-07-30
10809160528150HalyardPVHM222-02_0005PVHM222-022026-07-30
10809160528167HalyardSBHT00-06_0001SBHT00-062026-07-30
10809160528174HalyardDONS101-02_0001DONS101-022026-07-30
10809160528181HalyardQCEORSP123_0001QCEORSP1232026-07-30
10809160528198HalyardVMLR032-04_0005VMLR032-042026-07-30
10809160528051HalyardBPTJ33-01_0016BPTJ33-012026-07-29
10809160528075HalyardBMHT301-02_0007BMHT301-022026-07-29
10809160528082HalyardWINN121-11_0004WINN121-112026-07-29
10809160528099HalyardJCSP60F_0011JCSP60F2026-07-29
10809160528105HalyardESEY90-03_0016ESEY90-032026-07-29
10809160527856HalyardAVMD054_0004AVMD0542026-07-28
10809160527863HalyardAVMD052-02_0004AVMD052-022026-07-28
10809160527870HALYARDPVHM201-02PVHM201-022026-07-28
10809160527887HALYARDPVHM205-02PVHM205-022026-07-28
10809160527894HalyardOGDV68-02OGDV68-022026-07-28
10809160527900HalyardUPVD01-02UPVD01-022026-07-28

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