FDA.reportPublic FDA data

Direct Inject

Primary DI
07613327123272
Brand
Direct Inject
Company
Stryker Leibinger GmbH & Co. KG
Model
79-45910
Catalog number
79-45910
Device description
DirectInject On-Demand HA Cement
Published
2015-09-24
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
07613327123272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327123272076133271232727613327123272

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

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
07613327694482DELTA70-9234570-923452026-07-21
07613327694499DELTA70-9235070-923502026-07-21
04546540356703NA62-2350162-235012016-12-08
04546540356710NA64-0017564-001752016-12-08
04546540356727NA64-0017664-001762016-12-08
04546540366818NA62-9202362-920232016-10-19
07613154184026NA62-0031662-003162016-12-08
07613154185450NA62-0031562-003152016-12-08
04546540246974NA60-1548660-154862016-08-24
04546540246981NA60-1549660-154962016-08-24
04546540251862NA60-8014260-801422016-08-24
04546540287168NA6514-4-1806514-4-1802016-12-08
04546540356499NA60-1600560-160052016-08-24
04546540356505NA60-1600760-160072016-08-24
04546540356512NA60-1603560-160352016-08-24
04546540356529NA60-1605060-160502016-08-24
04546540356536NA60-1903560-190352016-08-24
04546540356543NA60-2005060-200502016-08-24
04546540356567NA60-9412060-941202016-08-24
04546540356628NA62-0030262-003022016-12-08

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