FDA.report

"T" HANDLE CANNULATED M8 VIOLET

Primary DI
08055727375629
Brand
"T" HANDLE CANNULATED M8 VIOLET
Company
HPF SRL
Model
H1500020169
Published
2022-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08055727375629PrimaryGS10

GMDN Terms

TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
895802853
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08055727370914STRAIGHT HANDLE HC CONN. ZIMMER01.11.10.07012022-09-09
08055727370921STRAIGHT HANDLE NEW HC CONN. ZIMMER01.11.10.07212022-09-09
08055727370938STRAIGHT HANDLE NEW HC CONN. A.O.01.11.10.07002022-09-09
08055727370945STRAIGHT HANDLE NEW HC CONN. A.O.01.11.10.07202022-09-09
08055727370952STRAIGHT HANDLE HC CONN. HUDSON01.11.10.07022022-09-09
08055727370969STRAIGHT HANDLE NEW HC CONN. HUDSON01.11.10.07222022-09-09
08055727371850STRAIGHT HANDLE UNIVERSAL CONN. ZIMMER01.11.10.07112022-09-09
08055727371867STRAIGHT HANDLE UNIVERSAL CONN. A.O.01.11.10.07102022-09-09
08055727371874STRAIGHT HANDLE UNIVERSAL CONN. HUDSON01.11.10.07122022-09-09
08055727372260THIN OSTEOTOME BLADE 76x8 WITH HOLE903000658002022-09-09
08055727372277THIN OSTEOTOME BLADE 76x10 WITH HOLE903000658102022-09-09
08055727372284THIN OSTEOTOME BLADE 76x12 WITH HOLE903000658202022-09-09
08055727372291THIN OSTEOTOME BLADE 76x20 WITH HOLE903000658302022-09-09
08055727372413THIN OSTEOTOME BLADE 127x8 WITH HOLE903000659502022-09-09
08055727372420THIN OSTEOTOME BLADE 127x10 WITH HOLE903000659602022-09-09
08055727372529THIN OSTEOTOME BLADE 76x8 WITH SLOT01.10.10.20552022-09-09
08055727372536THIN OSTEOTOME BLADE 76x10 WITH SLOT01.10.10.20562022-09-09
08055727372543THIN OSTEOTOME BLADE 76x12 WITH SLOT01.10.10.20572022-09-09
08055727372550THIN OSTEOTOME BLADE 76x20 WITH SLOT01.10.10.20582022-09-09
08055727372567THIN OSTEOTOME BLADE 127x8 WITH SLOT01.10.10.20592022-09-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04048844738150implaFit®implantcast GmbHLXH2026-03-24
07630542779244Surgical Manual InstrumentMedacta International SALXH2026-03-24
08053782783656BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783663BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783670BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783687BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783694BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783700BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783748TOOL VIP XL Instruments KitBRM EXTREMITIES SRLLXH2026-03-24
10888857596986K2M General InstrumentsK2M, INC.LXH2026-03-24
10888857596993K2M General InstrumentsK2M, INC.LXH2026-03-24
24026704941630PILLINGTELEFLEX INCORPORATEDLXH2026-03-23
00199150044016Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150067343Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043989Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043996Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150044009Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00198506089718ELMED INCORPORATEDELMED INCORPORATEDLXH2026-03-20
00810166520003X-PACEXPANDING INNOVATIONS, INC.LXH2026-03-20
00840314270221gSourceGSOURCE LLCLXH2026-03-20
00840314270238gSourceGSOURCE LLCLXH2026-03-20
10705034577678N/AMedos International SàrlLXH2026-03-20
00190446898801Arsenal FootTrilliant Surgical, LLCLXH2026-03-19
008890247065832 Piece Modular Shell Adapter BoltZimmer, Inc.LXH2026-03-19
008890247065902 Piece Modular Shell AdapterZimmer, Inc.LXH2026-03-19
03700879518589PECAPLASTY®NOVASTEPLXH2026-03-19
03700879518596PECAPLASTY®NOVASTEPLXH2026-03-19
07630542789984Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542789991Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542797576Surgical Manual InstrumentMedacta International SALXH2026-03-19