FDA.report

Batrik Long Tourny RL\1x29.5"\ BLUE

Primary DI
00690521011908
Brand
Batrik Long Tourny RL\1x29.5"\ BLUE
Company
Batrik Medical Manufacturing Inc
Model
K-2-29RL
Catalog number
K-2-29RL
Device description
Long Tourny, 1x 29.5", Blue, Non-sterile
Published
2021-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications

CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00690521011908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00690521011908006905210119086905210119080690521011908

GMDN Terms

TermDefinition
Arm/leg tourniquet, 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep Dry

Sterilization Methods

Method

Contacts

PhoneEmail
514-631-7988info@surgmed.com

Regulatory Flags

DUNS number
243880700
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00690521022683Batrik ShoozCovers™ SC-2112-NPBSC-2112-NPB2025-02-14
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