FDA.report

AUTO LOCK TOURNIQUET

Primary DI
00192896090682
Brand
AUTO LOCK TOURNIQUET
Company
SONTEC INSTRUMENTS, INC.
Model
1100-782
Catalog number
1100-782
Device description
AUTO LOCK TOURNIQUET
Published
2019-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MWHpulmonic valved conduit

Product Code Classifications

CodeDeviceSpecialtyClass
MWHPulmonic Valved ConduitUnknownf

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896090682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896090682001928960906821928960906820192896090682

GMDN Terms

TermDefinition
Arm/leg tourniquet, reusableA 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 will typically have a fastening mechanism (e.g., Velcro or a self-locking buckle) that allows adjustments to the degree of tightness. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
+1(800) 821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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