FDA.reportPublic FDA data

Aesclepius Locking Clamp, Standard

Primary DI
G485AESC10010
Brand
Aesclepius Locking Clamp, Standard
Company
Aesclepius Corporation
Model
AESC-1001
Device description
Single stainless steel locking bone clamp surgical instrument, standard size
Published
2025-01-13
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
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
G485AESC10010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone approximation clampA hand-held manual surgical instrument designed to grip and hold a bone or, being used in pairs one on either side of the fracture, to approximate the proximal and distal segment of a fractured bone during orthopaedic surgery. It is typically made of high-grade stainless steel and is designed with a double hooked, blade-like jaw at the distal end (this hooks over the upper edge of the bone) whilst an adjustable single hook is tightened against the lower edge of the bone through a screw mechanism. A traction bar may be employed to bridge the two bone clamps and using its screw mechanism, the fracture is drawn together. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
080782056
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
G485AESC10020Aesclepius Locking Clamp, LargeAESC-10022025-01-13
G485AESC20011Aesclepius Suture Cinch, Pack of 2AESC-20012025-01-13
G485AESC2001CS2Aesclepius Suture Cinch, Case of 5 Suture Cinch PacksAESC-2001-CS2025-01-13

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