Drill Stop Kit DSK

GUDID 00810157310026

Drill Stop Kit

Paragon Implant Mfg., LLC

Device sterilization/disinfection container, reusable
Primary Device ID00810157310026
NIH Device Record Keyd85d13ca-3f67-4667-a6c3-b2831c2a8271
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrill Stop Kit
Version Model NumberDSK
Catalog NumberDSK
Company DUNS118698566
Company NameParagon Implant Mfg., LLC
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com

Device Dimensions

Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter
Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter
Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter
Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter
Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter
Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter
Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter
Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter
Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter
Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter
Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter
Length64 Millimeter
Width43 Millimeter
Height26.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810157310026 [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

[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


[00810157310026]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-29
Device Publish Date2025-12-19

Devices Manufactured by Paragon Implant Mfg., LLC

00810157313331 - NizPlant Insertion Tool2026-02-23 NizPlant Insertion Tool, Long, 23mmL
00810157313775 - NizPlant Insertion Tool2026-02-23 NizPlant Insertion Tool, Short, 19mmL
00810157311566 - NizPlant Transfer2026-02-09 NizPlant NE Transfer, 4.3mmD-3.2mmP
00810157313706 - NizPlant Imp. Center Screw2026-02-09 NizPlant Imp. Center Screw (2 pcs)
00810157313751 - NizPlant Fixation Screw 2026-02-09 NizPlant Fix. Screw, Ex. Short (2 pcs)
00810157314130 - Ext. NizLoc Abutment Screw2026-02-09 Ext. NizLoc Abut Screw, 0.25mmL-4.8mmP
00810157314147 - Ext. NizLoc Abutment Screw2026-02-09 Ext. NizLoc Abut Screw, 1.25mmL-4.8mmP
00810157314154 - Ext. NizLoc Abutment Screw2026-02-09 Ext. NizLoc Abut Screw, 2.25mmL-4.8mmP

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