SURGICAL PROCEDURE PACK - Indication For Use: Surgical Procedure Packs is a - OMNIA SRL

Duns Number:447696675

Device Description: Indication For Use: Surgical Procedure Packs is a kit for oral implantology, used by denta 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 paperPossible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI"Model Number:X = alphabetic characterYYYY= n° of 4 number character

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More Product Details

Catalog Number

-

Brand Name

SURGICAL PROCEDURE PACK

Version/Model Number

12.XYYYY.00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724,K110724

Product Code Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

183a0d1f-653a-41dc-ae2f-58e5d39bea87

Public Version Date

June 17, 2022

Public Version Number

9

DI Record Publish Date

July 07, 2016

Additional Identifiers

Package DI Number

8056646500239

Quantity per Package

6

Contains DI Package

08056646500222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

12.T0010.00

"OMNIA SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 28