FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G141558294100
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
558-29410
Catalog number
558-29410
Device description
FOLEY Catheter tip punch, stainless steel, size 25 x 40 x 10 mm
Published
2023-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRYPunch, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G141558294100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Urethral drainage catheter punchA hand-held manual instrument designed for cutting a small hole (e.g., 0.3 mm diameter) into the distal end of a closed Foley catheter (usually 14.0 French or larger) to form a "Council tip Foley catheter", allowing it to be placed over a guidewire or ureteral catheter. The punch is made of high-grade stainless steel and is typically used in a sterile environment to open the end of the Foley catheter before it is used. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(609) 249-2697info@carnegiesurgical.com

Regulatory Flags#

DUNS number
017636482
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
G14150603080Carnegie Surgical LLC506-0308506-03082026-09-30
G141509455170Carnegie Surgical LLC509-45517509-455172026-09-30
G141510443190Carnegie Surgical LLC510-44319510-443192026-09-30
G141510586170Carnegie Surgical LLC510-58617510-586172026-09-30
G141511368200Carnegie Surgical LLC511-36820511-368202026-09-30
G141511368300Carnegie Surgical LLC511-36830511-368302026-09-30
G14151423610Carnegie Surgical LLC514-236514-2362026-09-30
G1415180500Carnegie Surgical LLC518-050518-0502026-09-30
G141518555120Carnegie Surgical LLC518-55512518-555122026-09-30
G141520422030Carnegie Surgical LLC520-42203520-422032026-09-30
G141520422040Carnegie Surgical LLC520-42204520-422042026-09-30
G141520426040Carnegie Surgical LLC520-42604520-426042026-09-30
G141521149260Carnegie Surgical LLC521-14926521-149262026-09-30
G1415241110Carnegie Surgical LLC524-111524-1112026-09-30
G14152810910Carnegie Surgical LLC528-1091528-10912026-09-30
G141528202010Carnegie Surgical LLC528-20201528-202012026-09-30
G14154212860Carnegie Surgical LLC542-1286542-12862026-09-30
G141546073500Carnegie Surgical LLC546-07350546-073502026-09-30
G14154661010Carnegie Surgical LLC546-6101546-61012026-09-30
G14154661030Carnegie Surgical LLC546-6103546-61032026-09-30

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