FDA.reportPublic FDA data

SURGIPROS

Primary DI
00810212935362
Brand
SURGIPROS
Company
Surgipros, LLC
Model
PL530SP
Device description
LAP BULLDOG APPLIER
Published
2026-07-30
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

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810212935362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810212935362008102129353628102129353620810212935362

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

Regulatory Flags#

DUNS number
058689193
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00810143904598SURGIPROS80-200SP2026-07-30
00810143904604SURGIPROS80-201SP2026-07-30
00810143904611SURGIPROS80-202SP2026-07-30
00810143904628SURGIPROS80-203SP2026-07-30
00810143904642SURGIPROS80-252SP2026-07-30
00810143904659SURGIPROS80-254SP2026-07-30
00810143904680SURGIPROS80-1868SP2026-07-30
00810143904697SURGIPROS80-1689SP2026-07-30
00810143904703SURGIPROS80-1869LP2026-07-30
00810143904710SURGIPROS4305-19-10SP2026-07-30
00810143904727SURGIPROS4305-19-20SP2026-07-30
00810143904840SURGIPROSTUN-6L025-62026-07-30
00810143904857SURGIPROSTUN-6L025-82026-07-30
00810143904864SURGIPROSTUN-6LC025-K2026-07-30
00810143904918SURGIPROSNRR5MM2026-07-30
00810143904925SURGIPROSNRR8MM2026-07-30
00810143904932SURGIPROSNRR10MM2026-07-30
00810143904949SURGIPROSNRR13MM2026-07-30
00810143904956SURGIPROSNRR17MM2026-07-30
00810143905045SURGIPROSCON-TEN-SP2026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810143904840SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904857SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904864SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909227SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909715SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909746SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934860SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934877SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934884SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934891SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935379SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935546SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935553SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935560SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935584SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935591SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935669SURGIPROSSurgipros, LLCGEN2026-07-30
B382SD919327220Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD919327230Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD919523070Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD919523080Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD920277290Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD920759990Surgical DirectSurgical Direct, Inc.GEN2026-07-29
00190776422158MillenniumAvalign Technologies, Inc.GEN2026-07-28
00190776422165MillenniumAvalign Technologies, Inc.GEN2026-07-28
00198506093319ELMED INCORPORATEDELMED INCORPORATEDGEN2026-07-28
B382SD375304150Surgical DirectSurgical Direct, Inc.GEN2026-07-28
B382SD375304200Surgical DirectSurgical Direct, Inc.GEN2026-07-28
B382SD9028541110Surgical DirectSurgical Direct, Inc.GEN2026-07-28
B382SD9153291000Surgical DirectSurgical Direct, Inc.GEN2026-07-28