Surgical Direct

Antrum Curette, Forward Cutting

Registry build 21.09.26
1manufacturer
5catalogue numbers in this listing

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code KAP
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Record

Regulatory record for Surgical Direct
Listed by Surgical Direct, Inc., United States
FDA product code KAP
Device type Curette, Nasal
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2020-04-29
Record revised 2024-04-17 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Sizes Outer diameter 6 to 13 mm

Catalogue Numbers

Catalogue numbers for Surgical Direct
Catalogue number Size Status
SD28809 Outer Diameter 11 mm In distribution
SD28559 In distribution
SD28709 Outer Diameter 6 mm In distribution
SD28659 Outer Diameter 11 mm In distribution
SD28759 Outer Diameter 13 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bausch + Lomb Bausch & Lomb Incorporated 22
Integra® Jarit® Integra LifeSciences Production Corporation 22
Aesculap Aesculap AG 21
V. Mueller Steris Corporation 20
Integra® Integra LifeSciences Production Corporation 19
Integra® Miltex® Integra LifeSciences Production Corporation 19
Sklar Sklar Corporation 19
Novo Surgical Novo Surgical, Inc. 18
Novo Surgical Inc. Novo Surgical, Inc. 16
Curette KLS-Martin L.P. 15
Jedmed Jedmed Instrument Company 14
MicroFrance® Integra Microfrance SAS 13

Showing 12 of 40. All products under Curette, Nasal

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