FDA.reportPublic FDA data

Betta Link Disposable Hard Bone Drill Bit

Primary DI
10818674028797
Brand
Betta Link Disposable Hard Bone Drill Bit
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
110045152
Catalog number
183100bsm
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
10818674028797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081867402879710818674028797

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
534123013
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818674021545Switchcut Femoral Guide Arm Point110026880148400bsm2026-05-18
10818674021552Switchcut Tibial Guide Arm PCL110026881148500bsm2026-05-18
10810128463291Back Drill Guide Bullet ID 4.5mmS25-3001-T149000su2026-05-13
10810128463307Back Drill Guide Bullet ID 6.0mmS25-3002-T150000su2026-05-13
10810128463574Rasp Up Bend 20°S36-0013-T901131su2026-05-13
10810128463581Rasp Down Bend 20°S36-0024-T901141su2026-05-13
108101284636284.5mm Can. Full Thickness DrillS250045A113045su2026-05-13
108101284636357.0mm Can. Full Thickness DrillS25-7000-AT113070su2026-05-13
108101284636428.0mm Can. Full Thickness DrillS25-8000-AT113080su2026-05-13
108101284636599.0mm Can. Full Thickness DrillS25-9000-AT113090su2026-05-13
10810128463666Back Drill Femoral Guide Arm RightS25-3200-T148200su2026-05-13
10810128463673Back Drill Tibial Guide to PointS25-3300-T148300su2026-05-13
10810128463697Meniscal Root ArmS25-3600-T148600su2026-05-13
10810128462775OsteoTak ArthrexAR-1902611018ar2026-05-05
10818674022207Suture passe110038984254001bsm2026-04-14
10810128462997Champion+ Suture Passer3910-600-001382000st2026-04-07
10810128463000Champion+ Suture Passer 3910-600-002382100st2026-04-07
10810128463024Champion+ Suture Passer 3910-600-003S382300st2026-04-07
10810128463185Hip Bone Pick 60°512404t512404t2026-03-19
10810128463192Hip 2.5 Grasper393400t393400t2026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536161836neon3Ulrich GmbH & Co. KGHTW2026-05-28
04052536161867neon3Ulrich GmbH & Co. KGHTW2026-05-28
09120125220273Shark Screw® drillsurgebright GmbHHTW2026-04-30
08053782783724BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-04-29
08059386744260Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386744277Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386742327Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742341Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742358Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742365Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742372Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742389Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742396Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742402Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386747957Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-10-27
08053782780464BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
08053782780471BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
G79151202112817G0WishFIXRed Star Contract Manufacturing Inc.HTW2025-10-06
09120125220044Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220051Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220068Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220075Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220082Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220099Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220105Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220112Shark Screw® drillsurgebright GmbHHTW2025-09-16
08809416065601Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065618Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065625Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066905Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24