FDA.reportPublic FDA data

Therapak

Primary DI
07312058462659
Brand
Therapak
Company
Therapak LLC
Model
ACSK37929
Catalog number
ACSK37929
Device description
Generic 12-Vial Prostate Biopsy Transport Kit (CS/30)
Published
2022-12-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
07312058462659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07312058462659073120584626597312058462659

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kit IVD, clinicalA collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791071165
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07312058462420TherapakACSK40011ACSK400112022-12-21
07312058462437TherapakACSK40012ACSK400122022-12-21
07312058462475TherapakACSK75098ACSK750982022-12-21
07312058462642TherapakACSK37928ACSK379282022-12-21
07312058462673TherapakACSK38533ACSK385332022-12-21
07312058462680TherapakACSK38534ACSK385342022-12-21
07312058462697TherapakACSK38869ACSK388692022-12-21
07312058462703TherapakACSK38870ACSK388702022-12-21
07312058462727TherapakACSK38872ACSK388722022-12-21
07312058462734TherapakACSK38873ACSK388732022-12-21
07312058462741TherapakACSK38879ACSK388792022-12-21
07312058462802TherapakACSK40002ACSK400022022-12-21
07312058462819TherapakACSK40056ACSK400562022-12-21
07312058462826TherapakACSK75099ACSK750992022-12-21
07312058462833TherapakACSK75100ACSK751002022-12-21
07312058462857TherapakACSK37939ACSK379392022-12-21
07312058462871TherapakACSK40003ACSK400032022-12-21
07312058462888TherapakACSK40004ACSK400042022-12-21
07312058462901TherapakACSK40010ACSK400102022-12-21
07312058462918TherapakACSK40031ACSK400312022-12-21

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
10809160472033HalyardAVID MEDICAL, INC.FCH2025-07-02
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