FDA.report

Button Holder - Suture Management

Primary DI
09421028111959
Brand
Button Holder - Suture Management
Company
ENZTEC LIMITED
Model
72205274
Catalog number
72205274
Device description
Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction
Published
2020-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09421028111959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09421028111959094210281119599421028111959

GMDN Terms

TermDefinition
Tendon/ligament graft preparation station postA component of a graft preparation station designed to be affixed to the station base to help position, clamp and tension a ligament and/or tendon graft being prepared for implantation. This device is typically made of high-grade stainless steel and is available in a variety of sizes and types such as adjustable or fixed graft posts, patellar tendon posts, soft tissue clamp posts, and tensioning posts. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
592616445
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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09421038412169Offset drive train, locking9209-13039209-13032026-03-09
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09421038411926Dist Fem Cut Block Connector – 8mm4240-77104240-77102026-02-27
09421038411933Dist Fem Cut Block Connector – 9mm4240-77114240-77112026-02-27
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