FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403117329
Brand
V. Mueller
Company
STERIS CORPORATION
Model
S-0457
Catalog number
S0457
Device description
BLADE V-T 15DEG ANG TITAN withTTH 23X100M
Published
2016-09-23
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
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964402000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964402000VERSATRAC (TM) LUMBAR RETRACTOR SYSTEMV. Mueller Neuro/Spine1997-01-23GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403117329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540311732910885403117329

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 a 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 a metal device, 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. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00724995363284NAHeadrestBF005072026-10-08
00724995363291NAHeadrestBF005082026-10-08
00724995363307NAHeadrestBF005092026-10-08
00724995363314NABF00510BF005102026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434458MillenniumAvalign Technologies, Inc.GZT2026-10-07
00190776434465MillenniumAvalign Technologies, Inc.GZT2026-10-07
00810220800591Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00810220800607Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00810220800614Adler Instrument CompanyAdler, Inc.GZT2026-10-07
00190776420406MillenniumAvalign Technologies, Inc.GZT2026-08-26
00190776417239MillenniumAvalign Technologies, Inc.GZT2026-08-19
00190776416997MillenniumAvalign Technologies, Inc.GZT2026-08-18
00724995355296V. MuellerSteris CorporationGZT2026-08-18
00724995355319V. MuellerSteris CorporationGZT2026-08-18
00724995355340V. MuellerSteris CorporationGZT2026-08-18
00724995355364V. MuellerSteris CorporationGZT2026-08-18
00724995355388V. MuellerSteris CorporationGZT2026-08-18
00190776408756MillenniumAvalign Technologies, Inc.GZT2026-08-03
00190776402167MillenniumAvalign Technologies, Inc.GZT2026-07-21
10381780537533Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
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10381780537649TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
00860003476802MindsEye Expandable PortPharaoh Neuro, Inc.GZT2022-04-18
00860003476819MindsEye Expandable PortPharaoh Neuro, Inc.GZT2022-04-18
00860003476826MindsEye Expandable PortPharaoh Neuro, Inc.GZT2022-04-18
00816744028459NICO BrainPathNICO CORPORATIONGZT2020-04-15
10381780344605Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
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10381780344629Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344636Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344643Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344650Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23