FDA.reportPublic FDA data

Surge Cardiovascular

Primary DI
00817278010910
Brand
Surge Cardiovascular
Company
Alliant Enterprises, LLC
Model
TOU-7903S-100
Catalog number
TOU-7903S-100
Device description
Pediatric Tourniquet Kit wSnare, 1 red 2 blue 3 clear, 5.5" length, 100ct
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817278010910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817278010910008172780109108172780109100817278010910

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula holder setA collection of sterile devices intended to help secure a cardiopulmonary bypass cannula to the underlying tissue in the operative field to minimize displacement of the cannula during cardiopulmonary bypass surgery. Popularly known as a `snugger?, it typically consists of a number of colour-coded plastic tubes which can be cut to length, and a metal wire snare. The snare is intended to grasp a purse-string suture and to pull it taut through the tube; a holding suture is tied around the tube and the cannula to keep the cannula in place. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
121170653
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817278010009Surge CardiovascularSUT-010SUT-0102016-09-23
10817278010016Surge CardiovascularSUT-013SUT-0132016-09-23
10817278010023Surge Cardiovascular213-013213-0132016-09-23
00817278010033Surge Cardiovascular213-010213-0102016-09-23
10817278010887Surge CardiovascularSUT-014SUT-0142016-09-23
10817278011952MicroSurgeSUT-M110SUT-M1102016-09-23
10817278011969MicroSurgeSUT-M114SUT-M1142016-09-23
10817278010115Surge Cardiovascular213-002213-0022016-09-23
10817278010122Surge Cardiovascular213-004213-0042016-09-23
10817278010955Surge Cardiovascular213-003213-0032016-09-23
10817278010962Surge Cardiovascular213-003NS213-003NS2016-09-23
10817278010269Surge CardiovascularCAR-1613SCAR-1613S2016-09-23
10817278010276Surge CardiovascularCAR-1615SCAR-1615S2016-09-23
20817278011355Surge CardiovascularCAR-1613CAR-16132016-09-23
10817278011990MicroSurgeBLM-22150BLM-221502016-09-23
10817278012003Terumo Cardiovascular SystemsT402210T4022102016-09-23
00817278012402Terumo Cardiovascular SystemsT402210T4022102018-04-25
10817278010139Surge Cardiovascular213-0251213-02512016-09-23
10817278010146Surge Cardiovascular213-026213-0262016-09-23
10817278011983Surge Cardiovascular213-0252213-02522016-09-23

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