FDA.report

ACCESSORY HANDLE

Primary DI
08057968716780
Brand
ACCESSORY HANDLE
Company
HPF SRL
Model
H0034000299
Published
2022-09-02
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
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications

CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08057968716780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08057968716780080579687167808057968716780

GMDN Terms

TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. 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
00810111227148K-WireTreace Medical Concepts, Inc.HWE2026-03-23
10885862661555N/AExactech, Inc.HWE2026-03-19
00888867529762Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529779Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529809Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529830Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529847Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531628Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531635Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531680Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531727Arthrex®ARTHREX, INC.HWE2026-03-16
09421038412145Cup reamer handle, offset, Z/H, lockingENZTEC LIMITEDHWE2026-03-09
09421038412152Offset coupling, Z/HENZTEC LIMITEDHWE2026-03-09
09421038412169Offset drive train, lockingENZTEC LIMITEDHWE2026-03-09
09421038412176Short Offset Cover – UnitedENZTEC LIMITEDHWE2026-03-09
09421038412183Handle – UnitedENZTEC LIMITEDHWE2026-03-09
09421038412299Cup reamer handle, offset, AO, lockingENZTEC LIMITEDHWE2026-03-09
09421038412305Offset coupling, AOENZTEC LIMITEDHWE2026-03-09
09421038412312Cup reamer handle, offset, AO, openENZTEC LIMITEDHWE2026-03-09
09421038412329Offset drive train, openENZTEC LIMITEDHWE2026-03-09
09421038412671Cup reamer handle, offset, Z/H, openENZTEC LIMITEDHWE2026-03-09
00810111225601ReamerTreace Medical Concepts, Inc.HWE2026-03-02
00810111225618ReamerTreace Medical Concepts, Inc.HWE2026-03-02
00810111225625ReamerTreace Medical Concepts, Inc.HWE2026-03-02
09421038411865Enztec Modular OCI XENZTEC LIMITEDHWE2026-02-27
09421038412138Enztec Modular OCI XRENZTEC LIMITEDHWE2026-02-27
00888867536746Arthrex®ARTHREX, INC.HWE2026-02-25
00888867536760Arthrex®ARTHREX, INC.HWE2026-02-25
00888867536777Arthrex®ARTHREX, INC.HWE2026-02-25
09421038412725Enztec Reamer 36mm - BridgebackENZTEC LIMITEDHWE2026-02-23