FDA.reportPublic FDA data

MIS 3.3 REAMER HANDLE

Primary DI
08055727374516
Brand
MIS 3.3 REAMER HANDLE
Company
HPF SRL
Model
H0032520099
Published
2022-09-08
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
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
08055727374516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055727374516080557273745168055727374516

GMDN Terms#

Term, Definition table
TermDefinition
Burring power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. 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
true
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
08057968716551STANDARD HANDLE M8 BLUEH50000600192022-09-09
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
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
00810111227971PinTreace Medical Concepts, Inc.HWE2026-10-12
00810111227988PinTreace Medical Concepts, Inc.HWE2026-10-12
03700879515687Airlock®NOVASTEPHWE2026-08-25
08800038061286EZXIMEDICOM CO., LTD.HWE2026-08-25
00850083430108SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430122SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430139SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00193982616472ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.HWE2026-08-14
00193982616489ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.HWE2026-08-14
03701089527897AMPLITUDEAMPLITUDE SASHWE2026-07-29
03701089542326AMPLITUDEAMPLITUDE SASHWE2026-07-29
00841731153135ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153142ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153159ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153166ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153173ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153180ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153197ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153203ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153210ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153227ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153234ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153241ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
03700879515540airlock®NOVASTEPHWE2026-07-10
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-06-28
04589551366217P300-2A100NAKANISHI INC.HWE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HWE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HWE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HWE2026-06-26
04589551366422PD-IN-2-120NAKANISHI INC.HWE2026-06-26