FDA.reportPublic FDA data

SURGIPROS

Primary DI
00810143904321
Brand
SURGIPROS
Company
Surgipros, LLC
Model
TUN-06025-C
Device description
TUNNELER 6MM X 25 CM SLIGHT CURVE WITH 6MM TIP
Published
2024-01-06
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
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143904321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143904321008101439043218101439043210810143904321

GMDN Terms#

Term, Definition table
TermDefinition
Vascular graft tunnellerA long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
4109600452info@surgipros.com

Regulatory Flags#

DUNS number
058689193
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810212930404SURGIPROSBTCD102026-05-28
00810212930411SURGIPROSBTCD092026-05-28
00810212930428SURGIPROSBTCD112026-05-28
00810212930435SURGIPROSBTCD122026-05-28
00810212930442SURGIPROSBTCD132026-05-28
00810212930459SURGIPROSBTCD142026-05-28
00810212933504SURGIPROSBTCD082026-05-28
00810212933511SURGIPROSBTCD092026-05-28
00810212933528SURGIPROSBTCD102026-05-28
00810212933535SURGIPROSBTCD112026-05-28
00810212933542SURGIPROSBTCD122026-05-28
00810212933559SURGIPROSBTCD132026-05-28
00810212933566SURGIPROSBTCD142026-05-28
00810143905779SURGIPROSWR412S2026-05-23
00810143907032SURGIPROSBC171SP2026-05-23
00810143907483SURGIPROSBC173SP2026-05-23
00810143907490SURGIPROS5005-44SP2026-05-23
00810143907537SURGIPROSBF113SP2026-05-23
00810212930374SURGIPROSBC181SP2026-05-23
00810212930480SURGIPROSBT041T2026-05-22

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