FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403175817
Brand
V. Mueller
Company
STERIS CORPORATION
Model
Z-0102DG
Catalog number
Z0102DG
Device description
SHADOW-LINE DISTRACTION KIT GENESIS CONTAINER CD3-5B
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
10885403175817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540317581710885403175817

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. 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
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403107030V. MuellerR1134R11342016-09-23
10885403133824V. MuellerTB1-1TB112018-03-19
10885403133831V. MuellerTB1-2TB122018-03-19
10885403133848V. MuellerTB1-5TB152018-03-19
10885403133855V. MuellerTB1-6TB162018-03-19
10885403133862V. MuellerTC2-2TC222016-09-24
10885403179020V. MuellerR1142R11422016-09-23
10885403179037V. MuellerR1623R16232018-03-19
10885403179129V. MuellerR1589R15892016-09-23
10885403179136V. MuellerR1590R15902016-09-23
10885403185311V. MuellerTB1-10TB1102018-03-19
10885403185328V. MuellerTB1-12TB1122018-03-19
10885403185335V. MuellerTB1-3TB132018-03-19
10885403185342V. MuellerTB1-4TB142018-03-19
10885403185359V. MuellerTB1-7TB172018-03-19
10885403185366V. MuellerTB2-1TB212018-03-19
10885403185373V. MuellerTB2-10TB2102018-03-19
10885403185380V. MuellerTB2-12TB2122018-03-19
10885403185397V. MuellerTB2-2TB222018-03-19
10885403185403V. MuellerTB2-3TB232018-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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