FDA.reportPublic FDA data

DRILL GUIDE 3.1MM

Primary DI
00850005827450
Brand
DRILL GUIDE 3.1MM
Company
Genesis Biologics, Inc.
Model
50DG0031
Catalog number
50DG0031
Device description
DRILL GUIDE 3.1MM
Published
2024-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005827450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005827450008500058274508500058274500850005827450

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.1Millimeter

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
Manufacturing date on label
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
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
00850005827306GENESIS AWL40AWL04540AWL0452023-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569679262Newclip InstrumentsNEWCLIP TECHNICSFZX2026-10-30
04250337121053Endoscope Adapter for iLESSYS® Delta LaminoscopeJoimax GmbHFZX2026-10-29
04250337121060Coupling nut for endoscope adapterJoimax GmbHFZX2026-10-29
04250337121077Adapter holderJoimax GmbHFZX2026-10-29
04250337121183Locking screw for endoscope adapterJoimax GmbHFZX2026-10-29
04250337122425Endoscope Adapter for LaminoscopeJoimax GmbHFZX2026-10-29
M739985202229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
00889024702295OsseoFitZimmer, Inc.FZX2026-10-27
00889024702301OsseoFitZimmer, Inc.FZX2026-10-27
04250337119210Counter Pusher, greenJoimax GmbHFZX2026-10-27
04250337119227Counter Pusher, yellowJoimax GmbHFZX2026-10-27
04250337119234Counter Pusher, redJoimax GmbHFZX2026-10-27
M209232940Rose Proximal Cutting GuideBIOPRO, INC.FZX2026-10-27
M20923295Rose Distal Cutting GuideBIOPRO, INC.FZX2026-10-27
M739985202530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
M739985203530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
04250337117933Punching Adapter for Working TubeJoimax GmbHFZX2026-10-22
04250337119180Guiding Tube, eccentrically cannulated, redJoimax GmbHFZX2026-10-22
04250337119197Guiding Tube, eccentrically cannulated, purpleJoimax GmbHFZX2026-10-22
04250337119203Working Tube with Handle, oblique 45°Joimax GmbHFZX2026-10-22
04250337119562Guiding Tube, conicalJoimax GmbHFZX2026-10-22
04250337119579Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119586Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119593Working Tube with crown half teeth tipJoimax GmbHFZX2026-10-22
04250337119647Working Tube with handle, Standard lipJoimax GmbHFZX2026-10-22
04250337119678Guiding rod, conical, longitudinal slantedJoimax GmbHFZX2026-10-22
04250337119791Working Tube with long lipJoimax GmbHFZX2026-10-22
04250337120834Working tube, long lipJoimax GmbHFZX2026-10-22
04250337121862Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22