FDA.reportPublic FDA data

SURGIPROS

Primary DI
00810143909647
Brand
SURGIPROS
Company
Surgipros, LLC
Model
013524SP
Device description
TUBE GRAFT SIZING 8MM
Published
2026-07-28
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
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143909647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143909647008101439096478101439096470810143909647

GMDN Terms#

Term, Definition table
TermDefinition
Ligament graft sizer, noninvasiveA surgical instrument that contains a series of holes of varying dimensions/sizes intended to be used in orthopaedic surgery [e.g., in anterior cruciate ligament (ACL) reconstruction surgery] to measure the size/diameter of a harvested graft to be implanted. It is used ex vivo [e.g., on the preparation table of the operating room (OR)] on a harvested graft. The measurement is subsequently used to determine the diameter of the tunnel drilled into the operative site (e.g., distal femur) for acceptance of the new graft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
4109600452rickroenser@surgipros.com

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
00810143904567SURGIPROS5005-519-17SP2026-07-31
00810143906158SURGIPROSBF310SP2026-07-31
00810143906349SURGIPROSFO190SP2026-07-31
00810143906356SURGIPROSFO191SP2026-07-31
00810143906448SURGIPROSMD4552026-07-31
00810143907834SURGIPROS385-100SP2026-07-31
00810143909197SURGIPROSMD570SP2026-07-31
00810143909265SURGIPROSEA030SP2026-07-31
00810143909302SURGIPROSEA015SP2026-07-31
00810143909616SURGIPROSPGAC312G2026-07-31
00810212931029SURGIPROSBF113SP2026-07-31
00810212931036SURGIPROSBF120SP2026-07-31
00810212931043SURGIPROSBF121SP2026-07-31
00810212931050SURGIPROSBF123SP2026-07-31
00810212931777SURGIPROSEA012SP2026-07-31
00810212931784SURGIPROSEA018SP2026-07-31
00810212931791SURGIPROSEA034SP2026-07-31
00810212931807SURGIPROSEA099SP2026-07-31
00810212931814SURGIPROSEA101SP2026-07-31
00810212931906SURGIPROSMB059SP2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776431495MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776432119MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776431136MillenniumAvalign Technologies, Inc.NBH2026-09-21
00190776431143MillenniumAvalign Technologies, Inc.NBH2026-09-21
00190776427160MillenniumAvalign Technologies, Inc.NBH2026-08-21
00190776427177MillenniumAvalign Technologies, Inc.NBH2026-08-21
00198506094170ELMED INCORPORATEDELMED INCORPORATEDNBH2026-08-18
07630345716743SportsMed InstrumentsMedacta International SANBH2026-08-17
07630345716750SportsMed InstrumentsMedacta International SANBH2026-08-17
B382SD319590Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD480084LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD48008SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481014SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481022LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752CBDYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752PT0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481755STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481756STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481760DYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD483003STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487193000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487223000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD5235320Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD142090Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD1814DK70Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD18252590Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD30609CH0Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD316390Surgical DirectSurgical Direct, Inc.NBH2026-07-31
00198506093258ELMED INCORPORATEDELMED INCORPORATEDNBH2026-07-28
00810143908534SURGIPROSSurgipros, LLCNBH2026-07-28