FDA.reportPublic FDA data

SURGIPROS

Primary DI
00810143906325
Brand
SURGIPROS
Company
Surgipros, LLC
Model
FK180SP
Device description
BENNETT BONE ELEVATOR AND RETRACTOR LARGE BLADE OVERALL LENGTH 9-3/4
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
GEGElevator, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143906325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143906325008101439063258101439063250810143906325

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
00810143904598SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904604SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904611SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904628SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904642SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906264SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906370SURGIPROSSurgipros, LLCGEG2026-07-30
00810143907254SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934068SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934075SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934082SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934099SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934105SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934112SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934129SURGIPROSSurgipros, LLCGEG2026-07-30
B382SD914665600Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD914665630Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD914665700Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD914665730Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD91466578100Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD91467110000Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD91467110010Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD91467110020Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD91467110030Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD91467110050Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD91469600Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD9147001930Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD9147091900Surgical DirectSurgical Direct, Inc.GEG2026-07-27
00190776421984MillenniumAvalign Technologies, Inc.GEG2026-07-23
00840306837401Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEG2026-07-21