FDA.report

Betta Link SR Reusable Obturator

Primary DI
10818674025871
Brand
Betta Link SR Reusable Obturator
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
110045218
Catalog number
184100bsm
Published
2022-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818674025871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081867402587110818674025871

GMDN Terms

TermDefinition
Arthroscopic obturatorA non-sterile, hand-held manual surgical instrument designed to fill the lumen of an arthroscopic sleeve (not included) to facilitate insertion of the sleeve into a joint (e.g., shoulder, knee) during arthroscopic examination or surgery. It is typically cannulated, made of metal, and available in a variety of sizes. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method

Regulatory Flags

DUNS number
534123013
Device count
1
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10810128463185Hip Bone Pick 60°512404t512404t2026-03-19
10810128463192Hip 2.5 Grasper393400t393400t2026-03-19
10810128462645Nitinol Loop Passer MEDACTA05.06.10.0022146000md2026-02-09
10810128462379GFS Instrumentation Tray3910-800-023tg5410st2026-02-01
10810128462386GFS Mini Tray3910-800-024tg52420st2026-02-01
10810128461792GFS Hohmann Retractor3910-800-017la524HB002st2026-01-18
10810128461808GFS Glenoid Lever, Double Prong3910-800-018la524HB004st2026-01-18
10810128461815GFS Subscapularis Spreader3910-800-019la524HB001st2026-01-18
10810128461822GFS Glenoid Drill3910-800-020la524130st2026-01-18
10810128461839GFS Glenoid Guide3910-800-021la524v00st2026-01-18
10810128461846GFS Small Probe3910-800-022la524pb0st2026-01-18
10810128461655GFS Switching Stick3910-800-003la900130st2026-01-15
10810128461662GFS Inline Coracoid Drill Guide3910-800-004la524t00st2026-01-15
10810128461679GFS Coracoid Drill3910-800-005la524p01st2026-01-15
10810128461686GFS Coracoid Top Hat Drill3910-800-006la524p00st2026-01-15
10810128461693GFS Top Hat Tap3910-800-007la524400st2026-01-15
10810128461709GFS Sharp Curved Osteotome3910-800-008la524800st2026-01-15
10810128461716GFS Subscapularis Channeler3910-800-009la524900st2026-01-15
10810128461747GFS Glenoid Offset Pin3910-800-012la524u00st2026-01-15
10810128461754GFS Coracoid Screw, 3.5mm3910-800-013la524f00st2026-01-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04048844738150implaFit®implantcast GmbHLXH2026-03-24
07630542779244Surgical Manual InstrumentMedacta International SALXH2026-03-24
08053782783656BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783663BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783670BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783687BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783694BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783700BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783748TOOL VIP XL Instruments KitBRM EXTREMITIES SRLLXH2026-03-24
10888857596986K2M General InstrumentsK2M, INC.LXH2026-03-24
10888857596993K2M General InstrumentsK2M, INC.LXH2026-03-24
24026704941630PILLINGTELEFLEX INCORPORATEDLXH2026-03-23
00199150044016Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150067343Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043989Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043996Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150044009Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00198506089718ELMED INCORPORATEDELMED INCORPORATEDLXH2026-03-20
00810166520003X-PACEXPANDING INNOVATIONS, INC.LXH2026-03-20
00840314270221gSourceGSOURCE LLCLXH2026-03-20
00840314270238gSourceGSOURCE LLCLXH2026-03-20
10705034577678N/AMedos International SàrlLXH2026-03-20
00190446898801Arsenal FootTrilliant Surgical, LLCLXH2026-03-19
008890247065832 Piece Modular Shell Adapter BoltZimmer, Inc.LXH2026-03-19
008890247065902 Piece Modular Shell AdapterZimmer, Inc.LXH2026-03-19
03700879518589PECAPLASTY®NOVASTEPLXH2026-03-19
03700879518596PECAPLASTY®NOVASTEPLXH2026-03-19
07630542789984Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542789991Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542797576Surgical Manual InstrumentMedacta International SALXH2026-03-19