Nitinex Memory Staple ST-122020

GUDID 00841731120045

Staple, Nitinex 12x20x20mm

VILEX IN TENNESSEE, INC.

Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile

Primary Device ID	00841731120045
NIH Device Record Key	e659bdce-3b61-4505-aba5-ec80e5d3aa27
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nitinex Memory Staple
Version Model Number	ST-122020
Catalog Number	ST-122020
Company DUNS	152008371
Company Name	VILEX IN TENNESSEE, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841731120045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112837

FDA Product Code

JDR	Staple, Fixation, Bone