FDA.report

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
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G485AESC2001CS2PrimaryHIBCC0
G485AESC20010Unit of UseHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
(858) 265-6307contact@aesclepiusmedical.com

Regulatory Flags

DUNS number
080782056
Device count
10
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
false

Other Devices From This Company

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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