FDA.report

Betta Link SR Disposable Hard Bone Drill Bit

Primary DI
10818674025840
Brand
Betta Link SR Disposable Hard Bone Drill Bit
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
1100456152
Catalog number
183100bsm
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
HTOReamer

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818674025840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081867402584010818674025840

GMDN Terms

TermDefinition
Ligament reconstruction instrument set, reusableA collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. This is a reusable device.

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

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