FDA.reportPublic FDA data

ClearShield (Non-Sterile)

Primary DI
00866453000109
Brand
ClearShield (Non-Sterile)
Company
Osteosymbionics, LLC
Model
IMP
Device description
PMMA Patient Specific Cranial Implant (Non-Sterile)
Published
2015-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K072601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072601000OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANTOsteosymbionics, LLC2007-12-10GXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866453000109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866453000109008664530001098664530001090866453000109

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, non-alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
858769651
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
00866453000123PK ShieldIMP-PK2015-10-26
00866453000130ST TemporalisSTT-502015-10-26
00866453000147ST TemporalisSTT-602015-10-26
00866453000116ClearShield (Sterile)SIMP2015-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188325839HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-20
00810188325914HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-20
00810188325938HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-20
00810188325945HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-19
00810188325884HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-14
00810188325891HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-14
00810188325853HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-13
00810188325563HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325815HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325860HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325877HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325846HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-09
00810188325785HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-08
00810188324801HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-07
00810188325761HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-07
00810188325617HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-06
00810188325778HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-06
00810188325716HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-05
00810188325792HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-05
00810188325808HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-05
00810188325709HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-30
00810188325600HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-29
00810188325655HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-28
00810188325594HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-25
00810188325679HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-24
00810188325624HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-21
00810188325631HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-21
00810188325457HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-04
00810188325464HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-04
00810188325303HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-26