FDA.reportPublic FDA data

STANDARD HANDLE M8 BLUE

Primary DI
08057968716551
Brand
STANDARD HANDLE M8 BLUE
Company
HPF SRL
Model
H5000060019
Published
2022-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08057968716551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057968716551080579687165518057968716551

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057968716544STANDARD HANDLE M8 BLACKH50000600092022-09-09
08057968716568STANDARD HANDLE M6 BLACKH50000600992022-09-09
08057968716575STANDARD HANDLE M6 BLUEH50000601092022-09-09
08057968716582STANDARD HANDLE CANNULATED M6 BLACKH50000601692022-09-09
08057968716599STANDARD HANDLE CANNULATED M6 BLUEH50000601792022-09-09
08057968716605STANDARD RATCHET HANDLE BLACKH50000600392022-09-09
08057968716612STANDARD RATCHET HANDLE BLUEH50000600492022-09-09
08057968719217STRAIGHT DEPTH GAUGE9087.10.0102022-09-09
08055727370785FLEX. CARDANIC SCREWDRIVER COATED HEX. 3,5 mm CONN. ZIMMER01.32.10.02902022-09-08
08055727374479MIS 3.3 REAMER HANDLEH00325110992022-09-08
08055727374486MIS 3.3 REAMER HANDLEH00325120992022-09-08
08055727374493MIS 3.3 REAMER HANDLEH00325130992022-09-08
08055727374509MIS 3.3 REAMER HANDLEH00325140992022-09-08
08055727374516MIS 3.3 REAMER HANDLEH00325200992022-09-08
08055727374523MIS 3.3 REAMER HANDLEH00325210992022-09-08
08055727374530MIS 3.3 REAMER HANDLEH00325220992022-09-08
08055727374547MIS 3.3 REAMER HANDLEH00325230992022-09-08
08055727374554MIS 3.3 REAMER HANDLEH00325240992022-09-08
08057968711525ADAPTER HC/HPFH00305000092022-09-08
08057968716407LIGHTENED TRIAL HEAD D42 mmH00500515062022-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
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B0842003000010Keos Lumbar InstrumentKEOSLXH2023-02-10
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B0842003000030Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000100Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000110Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000120Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000130Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000200Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000210Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000220Keos Lumbar InstrumentKEOSLXH2023-02-10
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B0842003000300Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000310Keos Lumbar InstrumentKEOSLXH2023-02-10
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B0842003000330Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000400Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000410Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000420Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000430Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000500Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000510Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000520Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000530Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000600Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000610Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000620Keos Lumbar InstrumentKEOSLXH2023-02-10