FDA.reportPublic FDA data

Therapak

Primary DI
00810185250356
Brand
Therapak
Company
Therapak LLC
Model
ACSK38879
Catalog number
ACSK38879
Device description
StoneScreen Collection and Transport Kit (CS/16)
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810185250349PrimaryGS10
00810185250356Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810185250349008101852503498101852503490810185250349
00810185250356008101852503568101852503560810185250356

GMDN Terms#

Term, Definition table
TermDefinition
Urine strainerA device designed to collect stones (calculi) from urine during normal micturition (urination). It is typically designed as a sieve-like container with handles for holding and emptying, and is typically mounted into a funnel/holder system that may be attached to a dedicated treatment table or chair. The collected stones are typically sent to the clinical laboratory for examination and composition determination to facilitate patient diagnosis and/or therapy. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791071165
Device count
16
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07312058462420TherapakACSK40011ACSK400112022-12-21
07312058462437TherapakACSK40012ACSK400122022-12-21
07312058462475TherapakACSK75098ACSK750982022-12-21
07312058462642TherapakACSK37928ACSK379282022-12-21
07312058462659TherapakACSK37929ACSK379292022-12-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G669CNPTLN1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, Non-SterileCorramedical Inc.NNK2026-04-07
00860013988029500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
00860013988074Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00827989007772Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007789Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007796Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
B24280EZEX21000Easy 2 Stool Extraction DeviceAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NNK2025-10-30
00810185250004TherapakTherapak LLCNNK2025-08-11
00810185250042TherapakTherapak LLCNNK2025-08-11
00810185250202TherapakTherapak LLCNNK2025-08-11
00810185250349TherapakTherapak LLCNNK2025-08-11
00810185250608TherapakTherapak LLCNNK2025-08-11
00810185250646TherapakTherapak LLCNNK2025-08-11
00810185250561TherapakTherapak LLCNNK2025-08-04
00810185250622TherapakTherapak LLCNNK2025-08-04
00840216128729QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
00840216128736QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
04038917086318Urine receptacle 500mlSarstedt Aktiengesellschaft & Co.KGNNK2025-05-19
00860013899264Paternity Test Kit 50Ditek Consulting, LLCNNK2025-05-06
00860013899288Paternity Test Kit 25Ditek Consulting, LLCNNK2025-05-06
00860011770268Covid 19 Testing KitDitek Consulting, LLCNNK2025-05-01
00613647027059FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027066FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027073FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027080FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30