Esthesiometers Suppliers
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Mizra Medical Ltd. | Address: 21 Hasadna Street, Holon 58814, Israel
Phone: +972-(355)-06645
FDA Registration: 3003993868
Products: External Catheters, Male External Catheters, External Catheter, Male, Esthesiometers (FDA Code: GXB), Non-Sterile Urosheath Type Incontinence Device (FDA Code: NNX), ...
Mizra Medical Ltd. engages in the production of esthesiometers and male external catheters. more...
Phone: +972-(355)-06645
FDA Registration: 3003993868
Products: External Catheters, Male External Catheters, External Catheter, Male, Esthesiometers (FDA Code: GXB), Non-Sterile Urosheath Type Incontinence Device (FDA Code: NNX), ...
Mizra Medical Ltd. engages in the production of esthesiometers and male external catheters. more...
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21 to 21 of 21 Esthesiometers suppliers Page: 1 [2]
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FDA Code / Regulation: GXB / 882.1500
An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.
