Nerve Block Tray
The Nerve Block Tray is a convenience kit assembling components needed to perform peripheral or central nerve block procedures for regional anesthesia or pain management. Classified as FDA Class 2 under regulation 21 CFR 868.5140 within the Anesthesiology medical specialty, it is subject to enforcement discretion under the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) submission when all criteria are satisfied. The product code is OGJ. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGJ
- Device Class
- FDA class 2
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
FEI Numbers
This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.