FDA.reportPublic FDA data

Betta Link Long Reusable Obturator

Primary DI
10818674028896
Brand
Betta Link Long Reusable Obturator
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
110045219
Catalog number
184200bsm
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10818674028896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081867402889610818674028896

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
534123013
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
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mm0234-109-105145105st2026-08-03
10810128463925VersiTomic 2-Fluted Cannulated Reamer Ø5.0mm234-113-050124050st2026-08-03
10810128463932VersiTomic 2-Fluted Cannulated Reamer Ø5.5mm234-113-055124055st2026-08-03
10810128463949VersiTomic 2-Fluted Cannulated Reamer Ø6.0mm234-113-060124060st2026-08-03
10810128463956VersiTomic 2-Fluted Cannulated Reamer Ø6.5mm234-113-065124065st2026-08-03
10810128463963VersiTomic 2-Fluted Cannulated Reamer Ø7.0mm234-113-070124070st2026-08-03
10810128463970VersiTomic 2-Fluted Cannulated Reamer Ø7.5mm234-113-075124075st2026-08-03
10810128463987VersiTomic 2-Fluted Cannulated Reamer Ø8.0mm234-113-080124080st2026-08-03
10810128463994VersiTomic 2-Fluted Cannulated Reamer Ø8.5mm234-113-085124085st2026-08-03
10810128464007VersiTomic 2-Fluted Cannulated Reamer Ø9.0mm234-113-090124090st2026-08-03
10810128464014VersiTomic 2-Fluted Cannulated Reamer Ø9.5mm234-113-095124095st2026-08-03
10810128464021VersiTomic 2-Fluted Cannulated Reamer Ø10.0mm234-113-100124100st2026-08-03
10810128464038VersiTomic 2-Fluted Cannulated Reamer Ø10.5mm234-113-105124105st2026-08-03
10810128464045VersiTomic 2-Fluted Cannulated Reamer Ø11.0mm124110st234-113-1102026-08-03
10810128464052VersiTomic 2-Fluted Cannulated Reamer Ø12.0mm234-113-120124120st2026-08-03
10810128464069VersiTomic 2-Fluted Cannulated Reamer Ø13.0mm234-113-130124130st2026-08-03
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmAR-6593-57Q159o570ar2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmAR-6593-59Q159o590ar2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmAR-6593-77Q159o770ar2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmAR-6593-97Q159o970ar2026-07-21

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Primary DI, Brand, Company table
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B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
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