N/A PCF-816

GUDID 08800043901072

Bridge Fixator *1.0mm, 16H

TDM Co., Ltd.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Primary Device ID	08800043901072
NIH Device Record Key	1131bafa-960d-4ae8-a3f3-d62c5a04d33e
Commercial Distribution Status	In Commercial Distribution
Brand Name	N/A
Version Model Number	PCF-816
Catalog Number	PCF-816
Company DUNS	557801921
Company Name	TDM Co., Ltd.
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	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08800043901072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191057

FDA Product Code

HRS	Plate, Fixation, Bone