21 CFR § 880.6025 - Absorbent tipped applicator. | 合法醫療器材資訊網
§ 880.6025 Absorbent tipped applicator.
(a) Identification. An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807[1] of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820[2] of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
References ...醫療器材許可證資料集 | 合法醫療器材資訊網
Product Classification | 合法醫療器材資訊網
Cotton Tipped Applicator | 合法醫療器材資訊網
KXG | 合法醫療器材資訊網
21 CFR § 880.6025 - Absorbent tipped applicator. | 合法醫療器材資訊網
Cotton Tipped Applicators | 合法醫療器材資訊網
Dynarex Cotton Tipped Applicators 6 inch 1000 ... | 合法醫療器材資訊網
Medical Swabs | 合法醫療器材資訊網
【舒妥牌棉棒】許可證字號:衛署醫器陸輸壹字第000232號
器材品名:舒妥牌棉棒許可證字號:衛署醫器陸輸壹字第000232號註銷狀態:已註銷註銷日期:2010/07/20註銷理由:自請註銷有效日期:...