FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403137174
Brand
V. Mueller
Company
STERIS CORPORATION
Model
T-0095
Catalog number
T0095
Device description
V. Mueller Neuro/Spine SHADOW-LINE SIDE-LOADING LOCKING RETRACTOR BLADE HANDLE
Published
2016-09-24
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
10885403137174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540313717410885403137174

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
DM exempt
true
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
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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
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