FDA.reportPublic FDA data

SURGIPROS

Primary DI
00810143904918
Brand
SURGIPROS
Company
Surgipros, LLC
Model
NRR5MM
Device description
NERVE ROOT RETRACTOR 5MM
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143904918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143904918008101439049188101439049180810143904918

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
00810143904925SURGIPROSNRR8MM2026-07-30
00810143904932SURGIPROSNRR10MM2026-07-30
00810143904949SURGIPROSNRR13MM2026-07-30
00810143904956SURGIPROSNRR17MM2026-07-30
00810143905045SURGIPROSCON-TEN-SP2026-07-30
00810143905380SURGIPROSBW0144003SP2026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083107Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00199150083879Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00810143904659SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904680SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904697SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904703SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904710SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904727SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904925SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904932SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904949SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904956SURGIPROSSurgipros, LLCGAD2026-07-30
00810143905045SURGIPROSSurgipros, LLCGAD2026-07-30
00810143905380SURGIPROSSurgipros, LLCGAD2026-07-30
00810143906387SURGIPROSSurgipros, LLCGAD2026-07-30
00810143906394SURGIPROSSurgipros, LLCGAD2026-07-30
00810143906400SURGIPROSSurgipros, LLCGAD2026-07-30
00810143907001SURGIPROSSurgipros, LLCGAD2026-07-30
00810143907094SURGIPROSSurgipros, LLCGAD2026-07-30
00810143908374SURGIPROSSurgipros, LLCGAD2026-07-30
00810143908558SURGIPROSSurgipros, LLCGAD2026-07-30
00810143908794SURGIPROSSurgipros, LLCGAD2026-07-30
00810143908800SURGIPROSSurgipros, LLCGAD2026-07-30
00810143908817SURGIPROSSurgipros, LLCGAD2026-07-30
00810143908824SURGIPROSSurgipros, LLCGAD2026-07-30
00810143908831SURGIPROSSurgipros, LLCGAD2026-07-30
00810143908848SURGIPROSSurgipros, LLCGAD2026-07-30
00810143909609SURGIPROSSurgipros, LLCGAD2026-07-30
00810212930343SURGIPROSSurgipros, LLCGAD2026-07-30
00810212933573SURGIPROSSurgipros, LLCGAD2026-07-30