TENSION SLEEVE 10mm

GUDID 04260463843392

Aktormed GmbH

Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder

Primary Device ID	04260463843392
NIH Device Record Key	dc258afa-b4b6-4030-b9a7-ec4b87682e76
Commercial Distribution Status	In Commercial Distribution
Brand Name	TENSION SLEEVE 10mm
Version Model Number	141339
Company DUNS	537223815
Company Name	Aktormed GmbH
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	false
Serial Number	true
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	04260463843392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171947

FDA Product Code

NAY	System, Surgical, Computer Controlled Instrument