FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD49129230
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD49129-23
Catalog number
SD49129-23
Device description
AV Fistula Tunneler, 23 cm, Straight Shaft, Kelly-Wick Tunneler Style
Published
2026-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZYGraft, Vascular, Stainless Steel Tunneler

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZYGraft, Vascular, Stainless Steel TunnelerCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD49129230PrimaryHIBCC0

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
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD9207261140Surgical DirectSD920726114SD9207261142022-12-05
B382SD905500140Surgical DirectSD90550014SD905500142022-11-30
B382SD017210000Surgical DirectSD0172-1000SD0172-10002026-08-21
B382SD13448970Surgical DirectSD13448-97SD13448-972026-08-21
B382SD16008970Surgical DirectSD16008-97SD16008-972026-08-21
B382SD161730Surgical DirectSD1617-3SD1617-32026-08-21
B382SD3028P0Surgical DirectSD3028PSD3028P2026-08-21
B382SD77205052000Surgical DirectSD77205-05-200SD77205-05-2002026-08-21
B382SD77205082000Surgical DirectSD77205-08-200SD77205-08-2002026-08-21
B382SD7720508TS2000Surgical DirectSD77205-08TS-200SD77205-08TS-2002026-08-21
B382SD77205252000Surgical DirectSD77205-25-200SD77205-25-2002026-08-21
B382SD83042110011NS0Surgical DirectSD83042-11001-1NSSD83042-11001-1NS2026-08-21
B382SD9017971000Surgical DirectSD901797100SD9017971002026-08-21
B382SD907300000Surgical DirectSD90730000SD907300002026-08-21
B382SD914775290Surgical DirectSD91477529SD914775292026-08-21
B382SD915039080Surgical DirectSD91503908SD915039082026-08-21
B382SD915039140Surgical DirectSD91503914SD915039142026-08-21
B382SD915039150Surgical DirectSD91503915SD915039152026-08-21
B382SD9227656000Surgical DirectSD922765600SD9227656002026-08-21
B382SD9144941010Surgical DirectSD914494101SD9144941012026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884908089783N/AN/AMedical Components, Inc.MZY2019-09-07
50884908089788N/AN/AMedical Components, Inc.MZY2019-09-07
00884908144680N/AMedical Components, Inc.MZY2019-08-28
00884908144697N/AMedical Components, Inc.MZY2019-08-28
00884908144703N/AMedical Components, Inc.MZY2019-08-28
00884908144710N/AMedical Components, Inc.MZY2019-08-28
00884908144727N/AMedical Components, Inc.MZY2019-08-28
00884908144741N/AMedical Components, Inc.MZY2019-08-28
50884908144685N/AMedical Components, Inc.MZY2019-08-28
50884908144692N/AMedical Components, Inc.MZY2019-08-28
50884908144708N/AMedical Components, Inc.MZY2019-08-28
50884908144715N/AMedical Components, Inc.MZY2019-08-28
50884908144722N/AMedical Components, Inc.MZY2019-08-28
50884908144746N/AMedical Components, Inc.MZY2019-08-28
00884908142044TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142051TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142068TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142075TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142049TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142056TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142063TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142070TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908145656N/AN/AMedical Components, Inc.MZY2019-08-10
00884908145663N/AN/AMedical Components, Inc.MZY2019-08-10
50884908145651N/AN/AMedical Components, Inc.MZY2019-08-10
50884908145668N/AN/AMedical Components, Inc.MZY2019-08-10
00884908039917TUNNELERTUNNELERMedical Components, Inc.MZY2017-07-28
50884908039912TUNNELERTUNNELERMedical Components, Inc.MZY2017-07-28
00884908031119TUNNELERMedical Components, Inc.MZY2017-05-18
00884908056402TUNNELERTUNNELERMedical Components, Inc.MZY2017-05-18