FDA.reportPublic FDA data

"Tourniquet Single Use NL Flat, 1"""

Primary DI
04038917398220
Brand
"Tourniquet Single Use NL Flat, 1"""
Company
SARSTEDT, INC.
Model
95.1007.101
Device description
Single use tourniquet, non-latex flat, 1 inch wide
Published
2023-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917398220PrimaryGS10
04038917263214Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917398220040389173982204038917398220
04038917263214040389172632144038917263214

GMDN Terms#

Term, Definition table
TermDefinition
Limb tourniquet, manual, single-useA strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-257-5101customerservice.us@sarstedt.com

Regulatory Flags#

DUNS number
035410179
Device count
2000
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917398763S-Monovette® POC Collect Kit51.5100.10051.5100.1002017-07-28
04038917087841Tissue Culture Coverslip 25 mm83.18402022-11-22
04038917134040Tissue Culture Coverslip 22 mm83.1840.0012022-11-22
04038917134057Tissue Culture Coverslip 13 mm83.1840.0022022-11-22
04038917554633Screw Cap Tube 101x16 RBS with saline51.540.3872022-12-04
04038917554671Screw Cap Tube 82x13 FB with saline51.550.1232022-12-04
04038917952569Screw Cap Tube 79x16 RB with saline51.506.3902022-12-04
04038917554640Screw Cap Tube 101x16 RBS with saline51.540.3872022-12-04
04038917554688Screw Cap Tube 82x13 FB with saline51.550.1232022-12-04
04038917952552Screw Cap Tube 79x16 RB with saline51.506.3902022-12-04
04038917033435Screw Cap Tube 120x17 mm, 15 ml, PS62.553.0022022-11-22
04038917033442Screw Cap Tube 120x17 mm, 15 ml, PS62.553.2052022-11-22
04038917033497Screw Cap Tube 120x17 mm, 15 ml, PP62.554.2052022-11-22
04038917075671Urine Monovette®, 10ML with luerlock10.252.0282022-11-22
04038917376334Screw Cap Tube 120x17 mm, 15 ml, PP62.554.1002022-11-22
04038917112949Screw Cap Tube 120x17 mm, 15 ml, PS62.553.0022022-11-22
04038917112987Screw Cap Tube 120x17 mm, 15 ml, PS62.553.2052022-11-22
04038917113144Screw Cap Tube 120x17 mm, 15 ml, PP62.554.2052022-11-22
04038917104494Urine Monovette®, 10ML with luerlock10.252.0282022-11-22
04038917006095Tissue Culture Coverslip 25 mm83.18402022-11-22

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