FDA.reportPublic FDA data

EKCOMED

Primary DI
00850000965010
Brand
EKCOMED
Company
Ekcomed, Inc.
Model
EKM-SR10B
Catalog number
EKM-SR10B
Device description
SUREtriever Suture Retriever
Published
2022-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000965010PrimaryGS10
10850000965017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000965010008500009650108500009650100850000965010
1085000096501710850000965017

GMDN Terms#

Term, Definition table
TermDefinition
Suture knot pusher, single-useA hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-517-1833info@ekcomed.com

Regulatory Flags#

DUNS number
119213735
Device count
10
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000965140EKCOMEDEKM-PCB00635EKM-PCB006352024-11-05
00850000965003EKCOMEDEKM-SD937EKM-SD9372022-10-27
00850000965027EKCOMEDEKM-CFM10559EKM-CFM105592022-10-27
00850000965034EKCOMEDEKM-CSD10573EKM-CSD105732022-10-27
00850000965041EKCOMEDEKM-SSS1606EKM-SSS16062022-10-27
00850000965058EKCOMEDEKM-TBC1644EKM-TBC16442022-10-27
00850000965065EKCOMEDEKM-DKP294EKM-DKP2942022-10-27
00850000965072EKCOMEDEKM-MCP401EKM-MCP4012022-10-27
00850000965089EKCOMEDEKM-SSS1606VEKM-SSS1606V2022-10-27
00850000965096EKCOMEDEKM-SMFM1064EKM-SMFM10642022-10-27
00850000965102EKCOMEDEKM-AD14407EKM-AD144072022-10-27
00850000965119EKCOMEDEKM-CFMA100EKM-CFMA1002022-10-27
00850000965126EKCOMEDEKM-SAN0195EKM-SAN01952022-10-27
00850000965133EKCOMEDEKM-PPR0634EKM-PPR06342022-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275174Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275181Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275198Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275204Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275211Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275228Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275518Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275730Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275747Intrace USAPILOTIS TECH LLCHTD2026-07-03
00190776421786MillenniumAvalign Technologies, Inc.HTD2026-06-24
00192896123502Stefan Bone Holding ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123519Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123526Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123533Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00810158210837PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211100PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211117PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211148PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211186PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211216PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211223PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
008401944957213P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HTD2026-06-10
008405368002683P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HTD2026-06-10
08806373899997BENCOXCorentec Co., LtdHTD2026-06-09
04052536162000neon3Ulrich GmbH & Co. KGHTD2026-06-08
04052536162017neon3Ulrich GmbH & Co. KGHTD2026-06-08
00810189451001Surgical DesignSurgical Design, Inc.HTD2026-06-06
G8142900SF3Garish ApparelsGARISH APPARELSHTD2026-06-06
G8142900SFFPPP3Garish ApparelsGARISH APPARELSHTD2026-06-06
G8142905SF3Garish ApparelsGARISH APPARELSHTD2026-06-06