FDA.reportPublic FDA data

Aesclepius Suture Cinch, Case of 5 Suture Cinch Packs

Primary DI
G485AESC2001CS2
Brand
Aesclepius Suture Cinch, Case of 5 Suture Cinch Packs
Company
Aesclepius Corporation
Model
AESC-2001-CS
Device description
Case of 5 Suture Cinch Packs, each with two Suture Cinches with curled nitinol snare
Published
2025-01-13
Public version status
New
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G485AESC2001CS2PrimaryHIBCC0
G485AESC20010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wire/ligature passer, single-useA sterile, hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(858) 265-6307contact@aesclepiusmedical.com

Regulatory Flags#

DUNS number
080782056
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G485AESC10010Aesclepius Locking Clamp, StandardAESC-10012025-01-13
G485AESC10020Aesclepius Locking Clamp, LargeAESC-10022025-01-13
G485AESC20011Aesclepius Suture Cinch, Pack of 2AESC-20012025-01-13

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