Surgical Procedure Pack

Indication For Use: Surgical Procedure Packs is a kit for oral implantology, used by dental professionals when performing surgical procedures. Surgical Procedure Packs are composed of…

Registry build 21.09.26

Indication For Use: Surgical Procedure Packs is a kit for oral implantology, used by dental professionals when performing surgical procedures. Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries. Surgical Procedure Packs may be packages as a combination of any of the following components: – Surgical gowns (various models) with or without hand towels – Surgical Drapes: – Mayo drape – Absorbent/liquid proof drapes (with or without adhesive) – Adhesive side drape – Liquid repellent drape with or without adhesive – Face mask – Protective caps – Sheath/tubing sleeve – Surgical aspirator with adaptor – Surgical gauze – Disinfection sponge and/or basin – Adhesive films – Syringe – Needles – Single-use scalpel – Small dental mirror/dental explorer/tweezer – Irrigation/infusion line – Stopcock and ramp for infusion – Waste bag for contaminated material – Bone collector – Saliva ejector – Basin – Medical paper Possible combination of any of the devices mentioned are identified with different UDI code listed in the section “Package DI” Model Number: X = alphabetic character YYYY= n° of 4 number character

24manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (11), Anhui (6), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRO
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Sino Protection (Hefei) Medical Products Co., Ltd. Hefei Anhui Contract manufacturer 18
Changzhou Holymed Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Donghai Xingchen NON-Woven Products Co., Ltd. North Donghai Development Zone, Lianyungang Jiangsu Contract manufacturer 7
Fengyang Jiehong Nonwoven Product Co., Ltd. Chuzhou Anhui Contract manufacturer 7
3A Medical Products Co., Ltd. Liu An Anhui Contract manufacturer 6
Cobes Industries (Jinzhai) Co., Ltd. Luan Anhui Contract manufacturer 6
Lianyungang Aiyeh Non-woven Products Co., Ltd. Lianyungang Jiangsu Contract manufacturer 6
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Ningbo Greetmed Medical Instruments Co., Ltd. Ningbo Zhejiang Specification developer 75
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71

Showing 12 of 24. All 24 manufacturers in China registered for General Surgery Tray

Record

Regulatory record for Surgical Procedure Pack
Listed by Omnia Medical, United States
FDA product code LRO
Device type General Surgery Tray
Device class Class 2
Regulation 21 CFR 878.4370
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K110724
Record published 2016-07-07
Record revised 2022-06-17 (version 9)

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 12.e0054.00 of 5, 12.e0960.00 of 6, 12.t0010.00 of 6, 12.t0001.00 of 6, 12.t0013.00 of 6, 12.t0002.00 of 6

Catalogue Numbers

Catalogue numbers for Surgical Procedure Pack
Catalogue number Size Status
12.XYYYY.00 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 67,931
Medline Industries, Inc. Medline Industries, Inc. 54,362
Avid TruCustom Avid Medical, Inc. 13,498
Halyard Avid Medical, Inc. 12,802
ACS American Contract Systems, Inc. 10,337
SurgiTrack Owens & Minor Distribution, Inc. 5,575
Aligned Medical Solutions Aligned Medical Solutions 3,490
SurgiTrackSM Owens & Minor Distribution, Inc. 3,364
DeRoyal Deroyal Industries, Inc. 2,770
Medline Medline Industries, Inc. 1,960
Henry Schein Henry Schein, Inc. 729
Stradis Stradis Healthcare 685

Showing 12 of 113. All products under General Surgery Tray

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