FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403071171
Brand
V. Mueller
Company
STERIS CORPORATION
Model
NL1279-002
Catalog number
NL1279002
Device description
V. Mueller RIGID HOLDING ROD ATTACHES TO SIDE RAIL SIZES UP TO 28MM OF OPERATING TABLE
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
K090272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090272000SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)Cardinal Health, Inc.2009-03-18GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403071171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540307117110885403071171

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)323-9088Customer_Support@BD.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
00724995239909V. MuellerDP11DP112026-10-15
00724995239916V. MuellerDP12DP122026-10-15
00724995239923V. MuellerDP13DP132026-10-15
00724995239930V. MuellerDP14DP142026-10-15
00724995239947V. MuellerDP15DP152026-10-15
00724995239985V. MuellerED112ED1122026-10-15
00724995239992V. MuellerED15ED152026-10-15
00724995240004V. MuellerED16ED162026-10-15
00724995240011V. MuellerED17ED172026-10-15
00724995240028V. MuellerED19ED192026-10-15
00724995240660V. MuellerPP11PP112026-10-15
00724995240677V. MuellerPP12PP122026-10-15
00724995240684V. MuellerPP125PP1252026-10-15
00724995240691V. MuellerPP13PP132026-10-15
00724995240707V. MuellerPP14PP142026-10-15
00724995241025V. MuellerR1051R10512026-10-15
00724995241049V. MuellerR1065R10652026-10-15
00724995241056V. MuellerR1067R10672026-10-15
00724995241063V. MuellerR1069R10692026-10-15
00724995241070V. MuellerR1072R10722026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436612MilleniumAvalign Technologies, Inc.GZT2026-10-20
00190776439736MilleniumAvalign Technologies, Inc.GZT2026-10-20
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
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
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