FDA.reportPublic FDA data

Orantech

Primary DI
06941691969143
Brand
Orantech
Company
Orantech Inc.
Model
TNC-GPS-CTC-014
Device description
"Reusable cylindrical tourniquet Cuffs,34""X4"",dual port,single bladder,blue"
Published
2023-02-12
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
06941691969143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941691969143069416919691436941691969143

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
10193489106015MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106022MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106039MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106046MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106053MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106060MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106077MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106084MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106091MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106107MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106114MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106121MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106138MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106145MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106152MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106169MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106176MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106183MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106190MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106206MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106213MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106220MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106237MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106244MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106251MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106268MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106275MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106282MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106299MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106305MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15