FDA.reportPublic FDA data

ACCESSORY HANDLE

Primary DI
08057968716780
Brand
ACCESSORY HANDLE
Company
HPF SRL
Model
H0034000299
Published
2022-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057968716780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057968716780080579687167808057968716780

GMDN Terms#

Term, Definition table
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 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
08057968716797ACCESSORY CONN. M8H00340003092022-09-02
08057968716803ACCESSORY TRACKERH00340004992022-09-02
08057968716810ACCESSORY CONN. M8x1H00340003192022-09-02
08057968716827ACCESSORY CONN. M10H00340003292022-09-02

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Primary DI, Brand, Company table
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