FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403189418
Brand
V. Mueller
Company
STERIS CORPORATION
Model
SU3615-442
Catalog number
SU3615442
Device description
V. Mueller MALLEABLE BLADE 3 X 12 inches 7.6 X 30.5CM
Published
2018-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
10885403189418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540318941810885403189418

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
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
10885403185540V. MuellerTB3-9TB392016-09-24
10885403185571V. MuellerTC2-12TC2122016-09-24
10885403185632V. MuellerTC2-8TC282016-09-24
10885403185649V. MuellerTC2-9TC292016-09-24
00724995362980STERIS4195 Surgical TableST01900002026-10-08
00724995362997STERIS4195 Surgical TableST01910002026-10-08
00724995363000STERIS4195 Surgical TableST01920002026-10-08
00724995363024STERIS4195 Surgical TableST0190110022026-10-08
00724995363031STERIS4195 Surgical TableST0191110222026-10-08
00724995363048STERIS4195 Surgical TableST0190110132026-10-08
00724995363116STERIS5195 Surgical TableST01580002026-10-08
00724995363123STERIS5195 Surgical TableST01590002026-10-08
00724995363147STERIS5195 Surgical TableST0158110022026-10-08
00724995363154STERIS5195 Surgical TableST0159110222026-10-08
00724995363161STERIS5195 Surgical TableST0158110132026-10-08
00724995363222NAHeadrestBF005012026-10-08
00724995363239NAHeadrestBF005022026-10-08
00724995363246NAHeadrestBF005032026-10-08
00724995363253NAHeadrestBF005042026-10-08
00724995363260NAHeadrestBF005052026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD922616100Surgical DirectSurgical Direct, Inc.FFO2026-10-09
B382SD922616110Surgical DirectSurgical Direct, Inc.FFO2026-10-09
B382SD907620220Surgical DirectSurgical Direct, Inc.FFO2026-09-30
B382SD9076671330Surgical DirectSurgical Direct, Inc.FFO2026-09-29
B382SD914180130Surgical DirectSurgical Direct, Inc.FFO2026-09-29
00810238290049PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
00850088713862PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
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