FDA.report

Vector

Primary DI
00810005666572
Company
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Model
HAM-1001T-DR35
Device description
Drill 3.5mm diameter cannulated instrument. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Published
2020-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
047486041
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00810005666572PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00810005666572PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
HTWBit, Drill1Orthopedic888.4540NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Cannulated surgical drill bit, single-use, non-sterileA non-sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device intended to be sterilized prior to use.

Device Sizes

TypeValueText
Outer Diameter3.5 Millimeter

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
210-545-3713diana@nvisionbiomed.com

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810005667227TrigonWD-1001T-WSLA2025-12-19
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00810135963268ImpactPP-1000T-0322025-09-24
00810135963282ImpactPP-1000T-0422025-09-24
00810135963329ImpactPP-1001T-CUT42025-09-24
00810135963374ImpactPP-1001T-CUT32025-09-24
00810135963404ImpactPP-1000T-DEP342025-09-24
00810135963411ImpactPP-1001T-SLAP2025-09-24
00810135963640ImpactKWIRE-14-127S2025-09-24
00810135963657ImpactINST-1000T-M2502025-09-24
00810135963336ImpactPP-1000T-3012025-09-23
00810135963343ImpactPP-1000T-4012025-09-23
00810135963169ImpactPP-1001T-3002025-09-22
00810135963183ImpactPP-1001T-4002025-09-22
00810135963251ImpactPP-1000T-3002025-09-22
00810135963275ImpactPP-1000T-4002025-09-22
00810135963381ImpactPP-1000T-2002025-09-22
00810135963619ImpactPP-30-502025-09-22
00810135963626ImpactPP-40-502025-09-22

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