FDA.reportPublic FDA data

RegenKit®-THT-T-U

Primary DI
00850033131208
Brand
RegenKit®-THT-T-U
Company
Regenlab USA LLC
Model
RK-THT-T-U
Published
2026-03-23
Public version status
Update
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
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0900480

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0900480

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033131208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033131208008500331312088500331312080850033131208

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
087434117
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033131178RegenKit-ATS-T-URK-ATS-T-U2025-10-31
00850033131185RegenKit-ATS-3-URK-ATS-3-U2025-10-31
00850033131215RegenKit®-BCT-T-URK-BCT-T-U2026-03-25
00850033131055RegenLab USARK-THT-3-U 2023-04-28
08500331310042RegenKit®-BCT-TRK-BCT-T2021-08-27
00850033131192Cellular MembraneCM-HA-1CM-HA-12025-12-04
00850033131116Enhanced HASE-EN-HA-12025-08-29
00850033131123Wound Care Accessory SetWCA-SET12025-08-08
00850033131109RegenLab USARK-THT-BMC-3-102024-04-18
00850033131093RegenKit Wound-GelRK-WG-1SE-RK-WG-12024-03-12
00850033131031RegenLab USARK-BCT-3-U 2023-04-28
00850033131048RegenLab USARK-BCT-3-20-U2023-04-28
00850033131062RegenLab USARK-THT-3-20-U2023-04-28
00850033131079RegenLab USARK-WG-22023-04-28
00850033131086RegenLab USAR-ET2023-04-28
00850033131024Accessory SetBCA-SET3-U2021-11-24
00850033131017Accessory SetBCA-SET3-202021-11-19
08500331310028Accessory SetBCA-SET3-U2021-10-22
08500331310035Accessory SetBCA-SET3-202021-10-22
08500331310011A-CP-Kit-3A-CP-32021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00301691863906NovoFine® Plus 29GNOVO NORDISK INC.FMI2026-07-31
10192253005066MonojectCardinal Health 200, LLCFMI2026-07-31
10192253005516MonojectCardinal Health 200, LLCFMI2026-07-31
00810094578053Curaplex®BOUND TREE MEDICAL, LLCFMI2026-07-30
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
10801902215175ARROWTELEFLEX INCORPORATEDFMI2026-07-29
10801902215182ARROWTELEFLEX INCORPORATEDFMI2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
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