FDA.reportPublic FDA data

AWL 4.5MM

Primary DI
00850005827429
Brand
AWL 4.5MM
Company
Genesis Biologics, Inc.
Model
50AWL045
Catalog number
50AWL045
Device description
AWL 4.5MM
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005827429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005827429008500058274298500058274290850005827429

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.5Millimeter

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
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
00850005827306GENESIS AWL40AWL04540AWL0452023-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376544519InvictusALPHATEC SPINE, INC.LXH2026-07-30
00193082164828ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167416ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167430ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167447ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167454ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167461ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167478ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167492ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00193082167508ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00199150081905Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-30
00810166521703X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523004X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523011X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00850041805863X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
04251631412526BEE PLIF CageNGMedical GmbHLXH2026-07-30
07899258632346Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258634647Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653242Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653259Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653266Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653280Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653297Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
09421028110853Tensioner, AP SizerENZTEC LIMITEDLXH2026-07-30
09421028110877Tensioner, BalancerENZTEC LIMITEDLXH2026-07-30
09421028110884Tensioner, DistractorENZTEC LIMITEDLXH2026-07-30
00198506093487ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093500ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093524ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093548ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29