FDA-Device2024-11-06Class II
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
Pro-Dex Inc
Hazard
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
Sold states
US distribution to FL only.
Affected count
2000
Manufactured in
2361 McGaw Ave, N/A, Irvine, CA, United States
Products
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0280-2025Don't want to check this manually?
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