INVISX™

Primary DI
40643169496970
Brand
INVISX™
Company
MEDTRONIC PS MEDICAL, INC.
Model
60110
Device description
LOCK 60110 INVISX SHELF PK 10 X 2 PK
Published
2015-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010361000MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900Medtronic PS Medical2001-05-07GXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40643169496970PackageGS120In Commercial Distribution
00643169496972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4064316949697040643169496970
00643169496972006431694969726431694969720643169496972

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bone flap fixation clampA sterile, non-metallic, non-bioabsorbable device designed to be partially implanted around the perimeter of a replaced cranial bone flap after a craniotomy to ensure structural stability during the healing period. It is typically made of biocompatible plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and is typically designed with internal and external flanges that are tensioned together over the bone of both the flap and skull and locked via a central stem. It may also be used for craniofacial bone fracture fixation. Its non-metallic design makes it more compatible with radiological imaging than metallic clips.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width2.54Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
089055867
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00643169483316NA8023 B2015-06-24
00643169498365NA250772015-07-14
00643169507517NA8023 A2015-06-25
00643169073623NA250772015-06-25
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00673978228969NA464222015-06-18
00673978246017NA272972015-07-21
00673978246031NA273022015-07-14
20643169466122N/A464402015-07-15
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00763000422684StrataMR246957MR2026-03-13
00673978226835NA8591-602015-11-25
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00763000422653Valve, StrataMR II, Regular46965MR2025-01-23
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00763000422691Unassembled Shunt Kit, StrataMR II, Regular46967MR2025-01-23

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