FDA.reportPublic FDA data

BLADES SUPPORT HANDLE (KNURLED)

Primary DI
08057968713550
Brand
BLADES SUPPORT HANDLE (KNURLED)
Company
HPF SRL
Model
H0050300199
Published
2022-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057968713550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057968713550080579687135508057968713550

GMDN Terms#

Term, Definition table
TermDefinition
Chisel/osteotome blade handleA hand-held manual surgical device that is an interchangeable component of a chisel or osteotome blade and that functions as a handle designed to mount a compatible blade of these types which is locked into place. Together, this device and the selected blade, become a single-bladed surgical instrument used by a physician for cutting/contouring bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
895802853
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057968712409CUP IMPACTOR M10H00310000992022-09-08
08057968712423CUP IMPACTOR M8x1H00312001992022-09-08
08057968712430CUP IMPACTOR M10H00310001992022-09-08
08057968716858CUP IMPACTOR M8x1H00313001992022-09-08
08057968716896CUP IMPACTOR M8H00316000992022-09-08
08057968716902CUP IMPACTOR M8x1H00316001992022-09-08
08057968716919CUP IMPACTOR M10H00316002992022-09-08
08057968716933CUP IMPACTOR 4.0 M.8H00342000992022-09-08
08057968716940CUP IMPACTOR 4.0 M8x1H00343000992022-09-08
08057968716957CUP IMPACTOR 4.0 M10H00344000992022-09-08
08057968716964CUP IMPACTOR 4.0 UNIVERSALH00345000992022-09-08
08057968718890CUP IMPACTOR M1001.15.10.05352022-09-08
08057968718906CUP IMPACTOR M1001.15.10.06352022-09-08
08057968718913CUP IMPACTOR M89CCI.13.0012022-09-08
08057968718920CUP IMPACTOR M8x101.15.10.06362022-09-08
08057968718937CUP IMPACTOR M8x101.15.10.06372022-09-08
08057968716780ACCESSORY HANDLEH00340002992022-09-02
08057968716797ACCESSORY CONN. M8H00340003092022-09-02
08057968716803ACCESSORY TRACKERH00340004992022-09-02
08057968716810ACCESSORY CONN. M8x1H00340003192022-09-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888867550322Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550339Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550346Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550353Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550360Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550377Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550384Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552692Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552708Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552715Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552722Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552739Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552746Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552753Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552760Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574564Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574571Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574588Arthrex®ARTHREX, INC.LXH2026-09-18
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04054896000909(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000916(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000923AdapterSilony Medical GmbHLXH2026-09-18