FDA.reportPublic FDA data

Surge Cardiovascular

Primary DI
10817278010887
Brand
Surge Cardiovascular
Company
Alliant Enterprises, LLC
Model
SUT-014
Catalog number
SUT-014
Device description
Curved Suture Guide, 4 Pack
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
GEJCarrier, Ligature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEJCarrier, LigatureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817278010887PackageGS14In Commercial Distribution
00817278010880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081727801088710817278010887
00817278010880008172780108808172780108800817278010880

GMDN Terms#

Term, Definition table
TermDefinition
Operative-site suture holderA device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. 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
00817278010132Surge Cardiovascular213-0251213-02512016-09-23
00817278010149Surge Cardiovascular213-026213-0262016-09-23
00817278010897Surge CardiovascularPER-1407S-C02PER-1407S-C022016-09-23
00817278010903Surge CardiovascularPER-1401S-C05PER-1401S-C052016-09-23
00817278011269Surge CardiovascularSSD-100ASSD-100A2016-09-23
00817278011696Surge Cardiovascular5756NS5756NS2018-03-27
00817278011979Surge Cardiovascular213-028213-0282016-09-23
00817278011986Surge Cardiovascular213-0252213-02522016-09-23
00817278012396Terumo Cardiovascular SystemsT402210T4022102018-04-25
00817278011276Surge CardiovascularSUC-4300SUC-43002016-09-23
00817278011757Surge CardiovascularSUC-0840SUC-08402016-09-23
10817278010009Surge CardiovascularSUT-010SUT-0102016-09-23
10817278010016Surge CardiovascularSUT-013SUT-0132016-09-23
10817278010023Surge Cardiovascular213-013213-0132016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16975808861300MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861317MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861324MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861331MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861348MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861355MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861362MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861379MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861386MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861303MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861310MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861327MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861334MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861341MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861358MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861365MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861372MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861389MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
10840113298782CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
10840113299765CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
20840113299076CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
00814707024043CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
00194613014438MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2025-08-01
00194613063443MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00194613091439MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00194613091484MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00887482041444Symmetry DeschampsASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15
00887482041451Symmetry DeschASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15
00887482054918Symmetry DeschampsASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15
00887482054925Symmetry DeschampsASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15