FIXIT Knotless & ecoFIX Knotless EPA9000315

GUDID 03760154009751

Screwdriver to be used with FIXIT Knotless and ecoFIX Knotless anchors for rotator cuff repair.

S.B.M

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

Primary Device ID	03760154009751
NIH Device Record Key	bb9e576d-aefb-4c3e-bdfd-200625471a0e
Commercial Distribution Status	In Commercial Distribution
Brand Name	FIXIT Knotless & ecoFIX Knotless
Version Model Number	Screwdriver
Catalog Number	EPA9000315
Company DUNS	772462123
Company Name	S.B.M
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	true
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	03760154009751 [Primary]

FDA Product Code

HXX	Screwdriver