CorVocet™

34 catalogue numbers from 00884450333341, listed by Merit Medical Systems, Inc., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26
3manufacturers in China registered for this device type
34catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (2), Zhejiang (1).

Chinese manufacturers registered for FDA product code FCG
Manufacturer City Province Registered as Device types
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Promisemed Hangzhou Meditech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 21
Suzhou Leapmed Healthcare Corporation Suzhou Jiangsu Contract manufacturer 3

Record

Regulatory record for CorVocet™
Listed by Merit Medical Systems, Inc., United States
FDA product code FCG
Device type Biopsy Needle
Device class Class 2
Regulation 21 CFR 876.1075
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2019-10-25
Record revised 2021-11-01 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Packaging Pack of 5, pack of 4

Catalogue Numbers

Catalogue numbers for CorVocet™
Catalogue number Size Status
00884450333341 Coaxial Length (cm)-9.4 cm In distribution
00884450476277 In distribution
00884450373736 Coaxial Gauge-19G In distribution
B Coaxial Gauge-13G In distribution
00884450333402 Coaxial Length (cm)-4.6 cm In distribution
00884450373705 Coaxial Length (cm)-9.5 cm In distribution
00884450333389 Coaxial Length (cm)-14.5 cm In distribution
00884450476147 Coaxial Length (cm)-9.5 cm In distribution
00884450333372 Coaxial Length (cm)-9.5 cm In distribution
00884450476178 In distribution
00884450738900 Coaxial Length (cm)-4.6 cm In distribution
00884450476246 In distribution
00884450333426 Coaxial Gauge-19G In distribution
00884450476130 Coaxial Gauge-15G In distribution
00884450373668 Coaxial Gauge-13G In distribution
00884450373729 Coaxial Length (cm)-19.5 cm In distribution
00884450373743 Coaxial Gauge-19G In distribution
00884450333327 Coaxial Gauge-15G In distribution
00884450476239 In distribution
00884450476215 In distribution
00884450333365 Coaxial Gauge-17G In distribution
00884450373651 Coaxial Gauge-13G In distribution
00884450373699 Coaxial Length (cm)-4.5 cm In distribution
00884450373750 Coaxial Gauge-19G In distribution
00884450476208 In distribution
00884450476109 Coaxial Gauge-13G In distribution
00884450333334 Coaxial Length (cm)-4.4 cm In distribution
00884450373675 Coaxial Gauge-15G In distribution
00884450333358 Coaxial Length (cm)-9.5 cm In distribution
00884450333396 Coaxial Length (cm)-19.5 cm In distribution
00884450476154 In distribution
00884450373682 Coaxial Gauge-15G In distribution
00884450333419 Coaxial Gauge-19G In distribution
00884450373712 Coaxial Length (cm)-14.5 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Biopsybell Biopsybell SRL 227
Biopsybell SRL Biopsybell SRL 130
Medline Industries, Inc. Medline Industries, Inc. 98
Themy M.D.L. S.R.L. 61
SemiCut M.D.L. S.R.L. 46
Temno® Merit Medical Systems, Inc. 37
Temno Carefusion 2200, Inc. 36
Truguide Bard Peripheral Vascular, Inc. 31
Temno Evolution® Merit Medical Systems, Inc. 28
ClearTip Finemedix 25
Magnum Bard Peripheral Vascular, Inc. 22
SemiCut Coax. M.D.L. S.R.L. 22

Showing 12 of 115. All products under Biopsy Needle

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K151373 2015-08-07

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer