REMOVAL SCREW KIT FOR OUTLINK2 RSK-E        

GUDID D7700701993

REMOVAL SCREW KIT FOR OUTLINK2

SWEDEN & MARTINA SPA

Dental implant/prosthesis surgical procedure kit
Primary Device IDD7700701993
NIH Device Record Keyc5489454-2365-4f52-b49c-cf87b55e8113
Commercial Distribution StatusIn Commercial Distribution
Brand NameREMOVAL SCREW KIT FOR OUTLINK2
Version Model NumberRSK-E        
Catalog NumberRSK-E        
Company DUNS433815198
Company NameSWEDEN & MARTINA SPA
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7700701993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

[D7700701993]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-23

Devices Manufactured by SWEDEN & MARTINA SPA

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D7702693313 - SURGICAL KIT 2025-04-28 SURGICAL KIT GS 5.0
D7702693393 - BONE PROFILER SLEEVE2025-04-28 BONE PROFILER SLEEVE 5.0
D7702693553 - PILOT DRILL2025-04-28 PILOT DRILL SLEEVE 5.0 D.2.00 L.4.00 MM
D7702693643 - COUNTERSINK DRILL2025-04-28 COUNTERSINK DRILL SLEEVE 5.0 D.5.00 MM
D7702693653 - COUNTERSINK DRILL2025-04-28 COUNTERSINK DRILL SLEEVE 5.0 D.4.25 MM
D7702693663 - COUNTERSINK DRILL2025-04-28 COUNTERSINK DRILL SLEEVE 5.0 D.3.80 MM
D7702693673 - COUNTERSINK DRILL2025-04-28 COUNTERSINK DRILL SLEEVE 5.0 D.3.30 MM
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