FDA.reportPublic FDA data

V. Mueller

Primary DI
70885403111510
Brand
V. Mueller
Company
STERIS CORPORATION
Model
M-1535
Catalog number
M1535
Device description
PIN SKULL ADULT DISPO SS 3/PK 12/BX
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBLHOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBLHolder, Head, Neurosurgical (Skull Clamp)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002276000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002276000PSI SKULL CLAMPV. Mueller Neuro/Spine2000-08-29HBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885403111515PackageGS112In Commercial Distribution
70885403111510PrimaryGS10
10885403111518Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088540311151520885403111515
7088540311151070885403111510
1088540311151810885403111518

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine immobilization head ring pinA threaded rod that is a component of a cervical spine immobilization system (commonly known as a Halo vest) designed to secure the head ring to the skull of the patient by penetrating the outer bone of the skull at brow level; four pins are typically required. It is typically made of, e.g., high-grade surgical steel or titanium (Ti), or it may be ceramic-tipped or made of non-ferromagnetic materials that allow magnetic resonance imaging (MRI) and reduces the possibility of an electric current passing to the patient causing imaging artefact and/or a burning at the point. It is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
021599373
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995237059V. MuellerCD75CCD75C2026-09-24
00724995237066V. MuellerCD75CBLACKCD75CBLACK2026-09-24
00724995237073V. MuellerCD75CBLUECD75CBLUE2026-09-24
00724995237080V. MuellerCD75CGOLDCD75CGOLD2026-09-24
00724995237097V. MuellerCD75CGREENCD75CGREEN2026-09-24
00724995237103V. MuellerCD75CPURPLECD75CPURPLE2026-09-24
00724995237110V. MuellerCD75CREDCD75CRED2026-09-24
00724995237127V. MuellerCD76BCD76B2026-09-24
00724995237134V. MuellerCD76BBLACKCD76BBLACK2026-09-24
00724995237141V. MuellerCD76BBLUECD76BBLUE2026-09-24
00724995237158V. MuellerCD76BGOLDCD76BGOLD2026-09-24
00724995237165V. MuellerCD76BGREENCD76BGREEN2026-09-24
00724995237172V. MuellerCD76BPURPLECD76BPURPLE2026-09-24
00724995237189V. MuellerCD76BREDCD76BRED2026-09-24
00724995237196V. MuellerCD76CCD76C2026-09-24
00724995237202V. MuellerCD76CBLACKCD76CBLACK2026-09-24
00724995237219V. MuellerCD76CBLUECD76CBLUE2026-09-24
00724995237226V. MuellerCD76CGOLDCD76CGOLD2026-09-24
00724995237233V. MuellerCD76CGREENCD76CGREEN2026-09-24
00724995237240V. MuellerCD76CPURPLECD76CPURPLE2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780253716MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256113MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256120MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256137MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256144MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256151MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256175MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256182MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256199MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256205MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256212MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256229MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256236MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256243MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256250MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256267MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256274MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256281MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256687MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780025757MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025764MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025771MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025788MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025795MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025818MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253334MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253341MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253358MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253365MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253372MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26