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
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-03
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01