FDA.reportPublic FDA data

Orantech

Primary DI
06941691969181
Brand
Orantech
Company
Orantech Inc.
Model
TNC-GPS-CTC-018
Device description
"Reusable cylindrical tourniquet Cuffs,20""X6"",dual port,dual bladder,dark blue"
Published
2023-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KCYTourniquet, Pneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941691969181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941691969181069416919691816941691969181

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, reusableA band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544423370
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970706360668ETCO2 SensorCTM-RP012020-12-25
06941691934233Orantech ET-3005R-PH-A2026-01-29
06941691934240Orantech ET-3005R-PH-I2026-01-29
06941691938279Orantech EL-PH3-90G-A2026-01-29
06941691948865Orantech EL-PH3-90G-I2026-01-29
06941691983132Orantech IBP-KR-MD0172026-01-29
06941691905431Orantech IBP-PH-2MIR402026-01-16
06941691982906Orantech IBP-GE-MD0172026-01-16
06941691982913Orantech IBP-SL-MD0172026-01-16
06941691982920Orantech IBP-NKB-MD0172026-01-16
06941691982937Orantech IBP-NKC-MD0172026-01-16
06941691982944Orantech IBP-DGB-MD0172026-01-16
06941691982951Orantech IBP-DGC-MD0172026-01-16
06941691982968Orantech IBP-DGD-MD0172026-01-16
06941691982975Orantech IBP-DGE-MD0172026-01-16
06941691982982Orantech IBP-MRB-MD0172026-01-16
06941691982999Orantech IBP-CR-MD0172026-01-16
06941691983002Orantech IBP-BLT-MD0172026-01-16
06941691983019Orantech IBP-KTN-MD0172026-01-16
06941691983026Orantech IBP-CL-MD0172026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M99592200250BFR3PTS BFR Tourniquet Instrument & Throwing Cuff Set Delfi Medical Innovations IncKCY2026-01-14
M99597580018L1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M99597580018R1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M99597580021R1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M995995000181Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000241Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000301Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000341Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000421Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000181Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000241Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000301Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000341Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
08809802646971DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
08809802646988DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
08809802646995DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
M99592500002BFR1PTS for BFR Generation 3 - Dual Channel SystemDelfi Medical Innovations IncKCY2025-06-17
16976514770009Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770016Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770023Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770030Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770047Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770054Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770061Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770078Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770085Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770092Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770108Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770115Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770122Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23