DEVICE: SURGICAL PROCEDURE PACK (08056646500222)

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Device Record History
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Device Identifier (DI) Information
SURGICAL PROCEDURE PACK
12.XYYYY.00
In Commercial Distribution

OMNIA SRL
08056646500222
GS1

1
447696675 *Terms of Use
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
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
Yes
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
33961 General surgical procedure kit, non-medicated, single-use
A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LRO General Surgery Tray (Kit)
KKX Drape, Surgical
FYA Gown, Surgical
FXX Mask, Surgical
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K110724 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
183a0d1f-653a-41dc-ae2f-58e5d39bea87
June 17, 2022
9
July 07, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
8056646500239 6 08056646500222 In Commercial Distribution 12.T0010.00
8056646500246 6 08056646500222 In Commercial Distribution 12.T0001.00
8056646500352 6 08056646500222 In Commercial Distribution 12.T0013.00
8056646500253 6 08056646500222 In Commercial Distribution 12.T0002.00
8056646500260 6 08056646500222 In Commercial Distribution 12.T0107.00
8056646500277 6 08056646500222 In Commercial Distribution 12.T0108.00
8056646500284 10 08056646500222 In Commercial Distribution 12.T0105.00
8056646500291 10 08056646500222 In Commercial Distribution 12.S5621.00
8056646500307 6 08056646500222 In Commercial Distribution 12.S4671.00
8056646500314 6 08056646500222 In Commercial Distribution 12.S4041.00
8056646500321 1 08056646500222 In Commercial Distribution 12.S4096.00
8056646500338 1 08056646500222 In Commercial Distribution 12.S4061.00
8056646500345 6 08056646500222 In Commercial Distribution 12.T0003.00
8056646500437 5 08056646500222 In Commercial Distribution 12.S9539.00
8056646500420 25 08056646500222 In Commercial Distribution 12.S9950.00
8056646500413 100 08056646500222 In Commercial Distribution 12.S9308.00
8056646500406 20 08056646500222 In Commercial Distribution 12.S9307.00
8056646500390 50 08056646500222 In Commercial Distribution 12.S9306.00
8056646500383 2 08056646500222 In Commercial Distribution 12.E0052.00
8056646500376 8 08056646500222 In Commercial Distribution 12.S6007.00
8056646500369 5 08056646500222 In Commercial Distribution 12.S5557.00
8056646500451 5 08056646500222 In Commercial Distribution 12.E0246.00
8056646500444 5 08056646500222 In Commercial Distribution 12.E0253.00
8056646500475 5 08056646500222 In Commercial Distribution 12.S9184.00
8056646500468 10 08056646500222 In Commercial Distribution 12.S8303.00
80566465000505 5 08056646500222 2016-12-12 Not in Commercial Distribution 12.E0054.00
805664650505 5 08056646500222 2016-12-12 Not in Commercial Distribution 12.E0054.00
8056646500505 5 08056646500222 In Commercial Distribution 12.E0054.00
8056646500512 10 08056646500222 In Commercial Distribution 12.S8891.00
08056646500529 30 08056646500222 In Commercial Distribution 12.S9835.00
08056646500536 15 08056646500222 In Commercial Distribution 12.E0777.00
08056646500543 10 08056646500222 In Commercial Distribution 12.E0815.00
08056646500550 10 08056646500222 In Commercial Distribution 12.S8317.00
08056646500567 10 08056646500222 In Commercial Distribution 12.E0276.00
08056646500581 6 08056646500222 2017-11-07 Not in Commercial Distribution 12.E0960.00
08056646500635 15 08056646500222 In Commercial Distribution 12.E1318.00
08056646500628 10 08056646500222 In Commercial Distribution 12.E1248.00
08056646500611 10 08056646500222 In Commercial Distribution 12.E1202.00
08056646500574 6 08056646500222 In Commercial Distribution 12.E0960.00
08056646500604 20 08056646500222 In Commercial Distribution 12.E1276.00
08056646500598 8 08056646500222 In Commercial Distribution 12.E1186.00
08056646500659 20 08056646500222 In Commercial Distribution 12.E0646.00
08056646500666 5 08056646500222 In Commercial Distribution 12.E1407.00
08056646500642 6 08056646500222 In Commercial Distribution 12.E1338.00
08056646500673 6 08056646500222 In Commercial Distribution 12.S9671.00
08056646500680 25 08056646500222 In Commercial Distribution 12.E1591.00
08056646500697 12 08056646500222 In Commercial Distribution 12.E1561.00
08056646500826 2 08056646500222 In Commercial Distribution 12.E1619.00
08056646500819 15 08056646500222 In Commercial Distribution 12.S6003.00
08056646500802 8 08056646500222 In Commercial Distribution 12.S4913.00
08056646500796 5 08056646500222 In Commercial Distribution 12.S8382.00
08056646500789 8 08056646500222 In Commercial Distribution 12.E2619.00
08056646500772 40 08056646500222 In Commercial Distribution 12.E2468.00
08056646500765 10 08056646500222 In Commercial Distribution 12.E2458.00
08056646500758 8 08056646500222 In Commercial Distribution 12.E2354.00
08056646500734 6 08056646500222 In Commercial Distribution 12.E1857.00
08056646500727 20 08056646500222 In Commercial Distribution 12.E2068.00
08056646500710 8 08056646500222 In Commercial Distribution 12.E1910.00
08056646500703 6 08056646500222 In Commercial Distribution 12.E1805.00
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+390524527453
info@omniaspa.eu
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