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
04052536161959neon3Ulrich GmbH & Co. KGHTD2026-05-28
04052536161966neon3Ulrich GmbH & Co. KGHTD2026-05-28
04052536161973neon3Ulrich GmbH & Co. KGHTD2026-05-28
D9282000201SUL0SMITH SAGGITAL SPLITTER-MODW.H. Holden, Inc.HTD2026-05-27
G4250601180My MedicalMy Medical Store LLCHTD2026-05-04
G4250601350My MedicalMy Medical Store LLCHTD2026-05-04
G4250602970My MedicalMy Medical Store LLCHTD2026-05-04
G4250602980My MedicalMy Medical Store LLCHTD2026-05-04
G425310840NC0My MedicalMy Medical Store LLCHTD2026-05-04
G4254402140My MedicalMy Medical Store LLCHTD2026-05-04
G4254403120My MedicalMy Medical Store LLCHTD2026-05-04
G8142900SFPP3Garish ApparelsGARISH APPARELSHTD2026-04-28
09348811015402INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-21
09348811012678INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012722INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012913INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811013163INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811014603INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811129345INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
10649111493270Trinity Sterile, Inc.SKLAR CORPORATIONHTD2024-12-12
G586UR6201390Novo SurgicalNOVO SURGICAL, INC.HTD2024-07-23
10195327656256Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HTD2024-07-10
10195327621100Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HTD2024-02-05
G508RSCMD4700Raw Surgical CorporationRAW SURGICAL CORPORATIONHTD2023-11-19
G1413040800Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G1413040820Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G1413040840Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G25003003120Halsted Mosquito Forceps 12.5cm StraightN S SURGICAL COMPANYHTD2023-01-31
G25003004120Halsted Mosquito Forceps 12.5cm CurvedN S SURGICAL COMPANYHTD2023-01-31
G25003051180Standard Tube Forceps 18cmN S SURGICAL COMPANYHTD2023-01-30