FDA.reportPublic FDA data

MIS 4.0 REAMER HANDLE CUP IMPACTOR

Primary DI
08057968716742
Brand
MIS 4.0 REAMER HANDLE CUP IMPACTOR
Company
HPF SRL
Model
H0034000099
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
08057968716742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057968716742080579687167428057968716742

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
08055727375285DROP HANDLE M8 BLUEH15000002092022-09-05
08055727375322DROP HANDLE CANNULATED M8 VIOLETH15000202192022-09-05
08055727375339DROP HANDLE CANNULATED M8 NIGHT BLUEH15000502192022-09-05
08055727375346DROP HANDLE CANNULATED M8 BLUEH15000002192022-09-05
08055727375353DROP HANDLE CANNULATED M8 BLACKH15000102192022-09-05
08055727375360"T" RATCHED HANDLE YELLOWH15000404092022-09-05
08055727375377"T" RATCHED HANDLE WHITEH15000304092022-09-05
08055727375384"T" RATCHED HANDLE VIOLETH15000204092022-09-05
08055727375391"T" RATCHED HANDLE NIGHT BLUEH15000504092022-09-05
08055727375407"T" RATCHED HANDLE CANNULATED NIGHT BLUEH15000504592022-09-05
08055727375414"T" RATCHED HANDLE CANNULATED YELLOWH15000404592022-09-05
08055727375421"T" RATCHED HANDLE CANNULATED WHITEH15000304592022-09-05
08055727375438"T" RATCHED HANDLE CANNULATED VIOLETH15000204592022-09-05
08055727375445"T" RATCHED HANDLE CANNULATED BLUEH15000004592022-09-05
08055727375452"T" RATCHED HANDLE CANNULATED BLACKH15000104592022-09-05
08055727375469"T" RATCHED HANDLE BLUEH15000004092022-09-05
08055727375476"T" RATCHED HANDLE BLACKH15000104092022-09-05
08055727375483"T" HANDLE M8 YELLOWH15000401592022-09-05
08055727375490"T" HANDLE M8 WHITEH15000301592022-09-05
08055727375506"T" HANDLE M8 VIOLETH15000201592022-09-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00841731153173ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153180ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153197ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
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10888857578142Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
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10888857578210Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578227Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578234Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578241Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578760Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20