FDA.reportPublic FDA data

DirectInject

Primary DI
07613327425475
Brand
DirectInject
Company
Stryker Leibinger GmbH & Co. KG
Model
79-45144
Catalog number
79-45144
Device description
EXTENDED CANNULA
Published
2018-12-11
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

Product Codes#

Code, Name table
CodeName
GXPMETHYL METHACRYLATE FOR CRANIOPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXPMethyl Methacrylate For CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143661000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143661000DirectInjectStryker2015-09-02GXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327425475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327425475076133274254757613327425475

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327097627CranialMask Tracker6000-390-0006000-390-0002017-03-13
07613327499711N/A8900-200-2008900-200-2002023-03-23
07613327551938N/A6002-710-0506002-710-0502022-07-26
07613327620306N/A6002-810-5006002-810-5002025-10-28
07613327616118N/A6002-810-0006002-810-0002024-08-22
07613327616255N/A6002-810-3006002-810-3002024-08-15
07613327616286N/A81-8104481-810442024-08-15
07613327638189N/A6002-810-1006002-810-1002024-08-15
07613327638196N/A6002-810-2006002-810-2002024-08-15
07613327579833N/A7000015775827000015775822024-08-07
07613327576542N/A8800-100-0008800-100-0002023-04-11
07613327500530N/A8000-060-0198000-060-0192023-03-24
07613327500615N/A8000-060-0168000-060-0162023-03-23
07613327500622N/A8000-060-0148000-060-0142023-03-23
07613327500639N/A8000-060-0158000-060-0152023-03-23
07613327500646N/A8000-060-0188000-060-0182023-03-23
07613327538328Cranial Guidance Software81-8104281-810422023-03-23
07613327538410Cranial Guidance Software6000-670-3006000-670-3002023-03-23
07613327500509N/A8000-040-0178000-040-0172023-03-22
07613327500523N/A8000-040-0188000-040-0182023-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.GXP2026-06-05
00888118150271IPSKLS-Martin L.P.GXP2025-12-23
00850391007450Permatage 10ccABYRX, INC.GXP2025-05-21
00888118144430IPSKLS-Martin L.P.GXP2024-10-08
00888118144447IPSKLS-Martin L.P.GXP2024-10-08
00888118144454IPSKLS-Martin L.P.GXP2024-10-08
00888118144461IPSKLS-Martin L.P.GXP2024-10-08
00888118144478IPSKLS-Martin L.P.GXP2024-10-08
00888118144485IPSKLS-Martin L.P.GXP2024-10-08
00888118144492IPSKLS-Martin L.P.GXP2024-10-08
00888118144508IPSKLS-Martin L.P.GXP2024-10-08
00888118144515IPSKLS-Martin L.P.GXP2024-10-08
00888118144522IPSKLS-Martin L.P.GXP2024-10-08
00888118144539IPSKLS-Martin L.P.GXP2024-10-08
00888118144546IPSKLS-Martin L.P.GXP2024-10-08
00888118144553IPSKLS-Martin L.P.GXP2024-10-08
00850391007245Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
08885013201307OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
08885013201314OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
00888118140050IPSKLS-Martin L.P.GXP2023-03-22
00888118140067IPSKLS-Martin L.P.GXP2023-03-22
00888118140074IPSKLS-Martin L.P.GXP2023-03-22
00888118140081IPSKLS-Martin L.P.GXP2023-03-22
00888118140098IPSKLS-Martin L.P.GXP2023-03-22
00888118140104IPSKLS-Martin L.P.GXP2023-03-22
00888118140111IPSKLS-Martin L.P.GXP2023-03-22
00888118140128IPSKLS-Martin L.P.GXP2023-03-22
00888118140135IPSKLS-Martin L.P.GXP2023-03-22
00888118140142IPSKLS-Martin L.P.GXP2023-03-22