Simply Surgical Kit Conical SSK-C

GUDID 10841307135876

Drills & Tools (Qty 19) Tray (Qty 1)

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Device sterilization/disinfection container, reusable
Primary Device ID10841307135876
NIH Device Record Keyb6475297-40fe-4649-936a-665107c233b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimply Surgical Kit Conical
Version Model NumberSSK-C
Catalog NumberSSK-C
Company DUNS868856969
Company NameIMPLANT DIRECT SYBRON MANUFACTURING LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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

Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110841307135876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307135876]

Moist Heat or Steam Sterilization


[10841307135876]

Moist Heat or Steam Sterilization


[10841307135876]

Moist Heat or Steam Sterilization


[10841307135876]

Moist Heat or Steam Sterilization


[10841307135876]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-09
Device Publish Date2025-09-01

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

10841307135869 - Simply Surgical Kit Legacy2025-09-09 Drills & Tools (Qty 22) Tray (Qty 1)
10841307135876 - Simply Surgical Kit Conical2025-09-09Drills & Tools (Qty 19) Tray (Qty 1)
10841307135876 - Simply Surgical Kit Conical2025-09-09 Drills & Tools (Qty 19) Tray (Qty 1)
10841307134855 - DIRECTarch™ Cylinder – 6.0mm2025-05-01
10841307135197 - DIRECTscan™ Adapter Kit - Empty2025-05-01
00841307135213 - DIRECTarch™ Direct to MUA Screw (10Pk)2025-05-01
10841307132110 - SimplyIconic™ / InterActive™ SMARTbase, Extra Narrow, Non-Engaging2025-02-10
10841307132127 - DIRECTguide™ Sleeve Narrow2025-02-10
00841307128598 - DIRECTguide™ Sleeve Narrow (5PK)2025-02-10

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