FDA.reportPublic FDA data

Instrument Ligature Passing and Knot Tying

Primary DI
00848657069700
Brand
Instrument Ligature Passing and Knot Tying
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
KP1618
Catalog number
KP1618
Device description
Instrument Ligature Passing and Knot Tying
Published
2023-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCFInstrument, Ligature Passing And Knot Tying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657069700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657069700008486570697008486570697000848657069700

GMDN Terms#

Term, Definition table
TermDefinition
Suture knot pusher, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18182272720customerservice@aed.md

Regulatory Flags#

DUNS number
839138955
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848657078368AEDAED UH8012026-04-23
00848657078276AEDAED 33310UL-R2026-04-13
00848657078283AEDAED 33310UL2026-04-13
00848657078290AEDAED 33321A-R2026-04-13
00848657078306AEDAED 33321A2026-04-13
00848657078313AEDAED 33310FG-R2026-04-13
00848657078320AEDAED 33310FG2026-04-13
00848657078337AEDAED 33310R-R2026-04-13
00848657078344AEDAED 33310R2026-04-13
00848657078351AEDAED 34321SL2026-04-13
00848657078269AEDJZM15922026-03-02
00848657078238AED8830BL2026-02-24
00848657078245AED8830CL2026-02-24
00848657078252AED8830FL2026-02-24
00848657078214AED501.50BS2026-02-18
00848657078221AED501.51BS2026-02-18
00848657023122AEDAED11275FE2026-01-23
00848657023139AEDAED27071TJ2026-01-23
00848657068956AED2717462026-01-23
00848657069236AEDAED27071-92026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090653ELMED INCORPORATEDELMED INCORPORATEDHCF2026-05-12
00198506090486ELMED INCORPORATEDELMED INCORPORATEDHCF2026-05-05
14026704937131WECKTELEFLEX INCORPORATEDHCF2026-04-24
00840343727451Gen2SURGIX MEDICAL LLCHCF2026-04-22
04058749044812NAFehling Instruments GmbH & Co. KGHCF2026-04-22
00198506090035ELMED INCORPORATEDELMED INCORPORATEDHCF2026-04-08
00198506089893ELMED INCORPORATEDELMED INCORPORATEDHCF2026-04-02
04058749121087NAFehling Instruments GmbH & Co. KGHCF2026-03-05
00198506088223ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-27
00198506088162ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-22
00198506088179ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-22
00198506087660ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-16
00198506087776ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-16
00848657077989AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HCF2026-01-13
00848657077996AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HCF2026-01-13
00850012846512C1® DEPTH LIMITERLSI Solutions, Inc.HCF2025-12-08
10850012846519C1® DEPTH LIMITERLSI Solutions, Inc.HCF2025-12-08
04058749118711NAFehling Instruments GmbH & Co. KGHCF2025-12-08
00190776413446MillenniumAvalign Technologies, Inc.HCF2025-10-09
00198506085963ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-03
00198506072956ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
00198506082214ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
00198506082221ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
G453521053112M0PEAK MEDICALPeak Medical Distribution Inc.HCF2025-10-01
00190776411916MillenniumAvalign Technologies, Inc.HCF2025-09-25
00840217909952Wiggins medicalEbner Medical, LLCHCF2025-09-17
00198506085581ELMED INCORPORATEDELMED INCORPORATEDHCF2025-09-12
00198506085024ELMED INCORPORATEDELMED INCORPORATEDHCF2025-09-05
00198506084812ELMED INCORPORATEDELMED INCORPORATEDHCF2025-08-26
G4533352105310PEAK MEDICALPeak Medical Distribution Inc.HCF2025-08-13