FDA.reportPublic FDA data

GENESIS DRILL BIT

Primary DI
00850005827351
Brand
GENESIS DRILL BIT
Company
Genesis Biologics, Inc.
Model
40DB0020
Catalog number
40DB0020
Device description
DRILL BIT 2.0MM
Published
2023-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005827351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005827351008500058273518500058273510850005827351

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(657) 888-6243ORDERS@GENESISBIOLOGICS.COM

Regulatory Flags#

DUNS number
016463487
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005827368AlternatiV+ Screw-In Anchor20BN475320BN47532024-10-08
00850005827375AlternatiV+ Screw-In Anchor20BN550320BN55032024-10-08
00850005827382AlternatiV+ Max Knotless Anchor20KPN475120KPN47512024-10-08
00850005827399DUAL PITCH AWL/TAPPER 4.75MM50AT047550AT04752024-10-08
00850005827405DUAL PITCH AWL/TAPPER 5.5MM50AT055050AT05502024-10-08
00850005827412AWL/TAPPER 4.5MM50AWLT4550AWLT452024-10-08
00850005827429AWL 4.5MM50AWL04550AWL0452024-10-08
00850005827436AWL 5.5MM50AWL05550AWL0552024-10-08
00850005827443AWL/TAPPER 5.5MM50AWLT5550AWLT552024-10-08
00850005827450DRILL GUIDE 3.1MM50DG003150DG00312024-10-08
00850005827467DRILL BIT 2.0MM50DB002050DB00202024-10-08
00850005827214GENESIS SCREW-IN SUTURE ANCHOR10B4500310B450032023-03-16
00850005827221GENESIS SCREW-IN SUTURE ANCHOR10B5500310B550032023-03-16
00850005827238GENESIS SCREW-IN SUTURE ANCHOR10B6500310B650032023-03-16
00850005827245GENESIS THREAD SCREW-IN SUTURE ANCHOR10N4750210N475022023-03-16
00850005827252GENESIS THREAD SCREW-IN SUTURE ANCHOR10N45500210N4550022023-03-16
00850005827269GENESIS PUSH-IN SUTURE ANCHOR10S3000210S300022023-03-16
00850005827276GENESIS HYBRID KNOTLESS DUAL THREAD ANCHOR10KPN475110KPN47512023-03-16
00850005827283GENESIS HYBRID KNOTLESS DUAL THREAD ANCHOR10KPN550110KPN55012023-03-16
00850005827290GENESIS ALL SUTURE ANCHOR10JS250310JS25032023-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400552MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400576MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400644MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402075MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402082MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402204MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400293MillenniumAvalign Technologies, Inc.HTW2026-07-17
18257200076536CETRAOrthofix US LLCHTW2026-07-17
18257200076574CETRAOrthofix US LLCHTW2026-07-17
18257200131211Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131228Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131273Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200163823PILLAR SA TiOrthofix US LLCHTW2026-07-17
18257200163854PILLAR SA TiOrthofix US LLCHTW2026-07-17
07630008439866APTUSMedartis AGHTW2026-07-16
07630037811374APTUSMedartis AGHTW2026-07-16
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
09353903030317OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
09353903030324OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
00190776395438MillenniumAvalign Technologies, Inc.HTW2026-07-13
00190446932406Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948216Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948483Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-06-24
00889795154507Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154514Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154521Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154606Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
08800089483433Drill bitJeil Medical CorporationHTW2026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTW2026-06-10