PERCUTANEOUS PIN 125MM ROSAS00161

GUDID 03760244030672

PERCUTANEOUS PIN 125MM instrument Rosa one (spine application) Percutaneous pin for implantation in the iliac crest

MEDTECH

Multi-purpose stereotactic surgery system

Primary Device ID	03760244030672
NIH Device Record Key	d2d628b9-4609-4587-8657-426aad5dbec0
Commercial Distribution Status	In Commercial Distribution
Brand Name	PERCUTANEOUS PIN 125MM
Version Model Number	ROSA3-198B
Catalog Number	ROSAS00161
Company DUNS	264502977
Company Name	MEDTECH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
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	03760244030672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182848

FDA Product Code

OLO	Orthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

[03760244030672]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2019-12-20
Device Publish Date	2019-11-18

On-Brand Devices [PERCUTANEOUS PIN 125MM]

03760244030672	PERCUTANEOUS PIN 125MM instrument Rosa one (spine application) Percutaneous pin for implantation
03760244031419	PERCUTANEOUS PIN (125MM) instrument Rosa one 3.1 (spine application) Percutaneous pin for implan
03760244033482	"PERCUTANEOUS PIN (125MM) instrument Rosa one 3.1 (spine application) Percutaneous pin for impla

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.