FDA.report

Brasseler

Primary DI
00083208720451
Brand
Brasseler
Company
Suncoast Dental, Inc
Model
TTAP 4.5x20
Catalog number
TTAP 4.5x20
Device description
Tapered Tap 4.5mm diameter x 20mm length, Non-Irrigated A metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of Dental Implants. It is made of high-grade stainless steel, can be used in a dental hand piece or manually with a ratchet
Published
2021-01-29
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
false

Related Records

Product Codes

CodeName
HWXTap, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00083208720451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208720451000832087204510832087204510083208720451

GMDN Terms

TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Device Sizes

TypeValueUnit
Length20Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-888-360-5550tatumcompliance@gmail.com

Regulatory Flags

DUNS number
078352849
Device count
1
DM exempt
true
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

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