KOMET GUIDE PIN/SCREW GS901A.050.032

GUDID E226049152K41

Gebr. Brasseler GmbH & Co. KG

Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use

Primary Device ID	E226049152K41
NIH Device Record Key	409c546b-c650-4aee-a604-eef71a298b76
Commercial Distribution Status	In Commercial Distribution
Brand Name	KOMET GUIDE PIN/SCREW
Version Model Number	GS901A.050.032
Catalog Number	GS901A.050.032
Company DUNS	317409001
Company Name	Gebr. Brasseler GmbH & Co. KG
Device Count	20
DM Exempt	true
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	14053613208151 [Primary]
GS1	84053613208150 [Unit of Use]
HIBCC	E226049152K41 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K131264

FDA Product Code

HWC	Screw, Fixation, Bone