FDA.reportPublic FDA data

MSI

Primary DI
00810130207411
Brand
MSI
Company
Modern Surgical Instruments LLC
Model
769-02
Device description
BB System Basic Stainless Steel Set includes 769-08 BB Retractor Right (01)810130200313(10)769-13 BB Retractor Left (01)810130200320(10)769-18 BB Retractor Offset (01)810130200337(10)769-35 Handle (01)810130200047(10)767-50 BB Blade with Teeth (Titanium) 22.5mm x 34mm (01)810130200399(10)767-51 BB Blade with Teeth (Titanium) 22.5mm x 40mm (01)810130200405(10)767-52 BB Blade with Teeth (Titanium) 22.5mm x 45mm (01)810130200412(10)767-53 BB Blade with Teeth (Titanium) 22.5mm x 50mm (01)810130200429(10)767-54 BB Blade with Teeth (Titanium ) 22.5mm x 55mm (01)810130200436(10)767-55 BB Blade with Teeth (Titanium) 22.5mm x 60mm (01)810130200443(10)767-57 BB Blade with Teeth (Titanium) 22.5mm x 70mm (01)810130200450(10)767-60 BB Blunt Blade (Titanium) 22.5mm x 34mm (01)810130200474(10)767-61 BB Blunt Blade (Titanium) 22.5mm x 40mm (01)810130200481(10)767-62 BB Blunt Blade (Titanium) 22.5mm x 45mm (01)810130200498(10)767-63 BB Blunt Blade (Titanium) 22.5mm x 50mm (01)810130200504(10)767-64 BB Blunt Blade (Titanium) 22.5mm x 55mm (01)810130200511(10)767-65 BB Blunt Blade (Titanium) 22.5mm x 60mm (01)810130200528(10)767-67 BB Blunt Blade (Titanium) 22.5mm x 70mm (01)810130200535(10)767-40 BB Blade with Teeth (Titanium) 26.5mm x 40mm (01)810130200542(10)767-41 BB Blade with Teeth (Titanium) 26.5mm x 47mm (01)810130200559(10)767-42 BB Blade with Teeth (Titanium) 26.5mm x 55mm (01)810130200566(10)767-45 BB Blunt Blade (Titanium) 26.5mm x 40mm (01)810130200573(10)767-46 BB Blunt Blade (Titanium) 26.5mm x 47mm (01)810130200580(10)767-47 BB Blunt Blade (Titanium) 26.5mm x 55mm (01)810130200597(10)968-77 Sterilizing Instrument Case with Lid (01)810130200108(10)
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FFORetractor, Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810130207411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810130207411008101302074118101302074110810130207411

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118447158
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B4193533010Maxtown Medical3-533-012026-08-27
00810130207459MSIFSP22462026-08-18
00810130207466MSIFSP2390A2026-08-18
00810130207473MSIFSP2390B2026-08-18
00810130207480MSIFSP22322026-08-18
00810130207497MSIFSP22332026-08-18
00810130207503MSIFSP22342026-08-18
00810130207510MSIFSP22442026-08-18
00810130207527MSIFSP22452026-08-18
00810130207534MSIFSP26972026-08-18
00810130207435MSI100012026-07-14
00810130207404MSI83.72902026-04-01
00810130207367MSI99-00462026-03-12
00810130207374MSI99-00362026-03-12
00810130207381MSI99-00472026-03-12
00810130207398MSI99-00372026-03-12
00810130207350MSI47-03702026-02-20
00810130207343MSI71102026-02-16
B4194907540MSI49-07542022-08-03
B4197129690MSI71-29692022-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047074694GimmiGimmi GmbHFFO2026-08-14
B382SD921405170Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD93415040Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD459000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460350Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460360Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467010Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467020Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467030Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467040Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467050Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD48250Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493680Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493690Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493770Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD6213120Surgical DirectSurgical Direct, Inc.FFO2026-08-03
00190776407483MillenniumAvalign Technologies, Inc.FFO2026-07-31
B382SD14174550Surgical DirectSurgical Direct, Inc.FFO2026-07-31
B382SD90712216T0Surgical DirectSurgical Direct, Inc.FFO2026-07-29
B382SD907581320Surgical DirectSurgical Direct, Inc.FFO2026-07-24
B382SD9075041030Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530128T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530129T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907573330Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9075800910Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907580150Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9076231100Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD77550140Surgical DirectSurgical Direct, Inc.FFO2026-07-14
B382SD918174150Surgical DirectSurgical Direct, Inc.FFO2026-07-13