G919554

GUDID 00841379102281

G10 OFFSET T-HANDLE, 1/4 SQ. SECURE SHAFT, 100 IN-LB TORQUE LIMITING

HYHTE HOLDINGS, INC.

Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting

Primary Device ID	00841379102281
NIH Device Record Key	603890c0-d87b-464b-9972-f273cefda030
Commercial Distribution Status	In Commercial Distribution
Version Model Number	G919554
Catalog Number	G919554
Company DUNS	073029645
Company Name	HYHTE HOLDINGS, 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	false
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	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379102281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153446

FDA Product Code

LXH	Orthopedic Manual Surgical Instrument