FDA.reportPublic FDA data

HYDROSET

Primary DI
07613154274994
Brand
HYDROSET
Company
Stryker Leibinger GmbH & Co. KG
Model
79-43903
Catalog number
79-43903
Device description
3CC HYDROSET INJECTABLE 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
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613154274994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613154274994076131542749947613154274994

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA 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 does not include an antimicrobial agent(s). 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

Regulatory Flags#

DUNS number
316153956
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540000057COLORADOAC2000AC20002016-08-24
04546540366634NA62-0019262-001922016-12-08
07613153170549NA60-1672060-167202016-08-24
07613252578208NA78-2102878-210282015-07-03
07613252578215NA78-2002878-200282015-07-03
07613252578222NA78-2002078-200202015-07-03
07613252578239NA78-2102078-210202015-07-03
07613252599647NA78-3002078-300202015-07-03
07613252599654NA78-3002878-300282015-07-03
07613252599661NA78-3102078-310202015-07-03
07613252599678NA78-3102878-310282015-07-03
07613327392715DELTA70-7620170-762012018-06-07
04546540364883NA50-1290050-129002023-02-13
07613327369489AXS62-1217862-121782019-09-11
04546540246332NA60-1010460-101042016-08-24
04546540246356NA60-1010860-101082016-08-24
04546540246387NA60-1011260-101122016-08-24
04546540256805NA62-0053462-005342016-10-19
04546540258991NA62-1740162-174012016-10-19
04546540274175NA64-0010564-001052016-12-08

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