FDA.report

Certain

Primary DI
00844868041030
Brand
Certain
Company
BIOMET 3I, LLC
Model
ISRT05N
Device description
CERTAIN® SCREW REMOVAL TOOL DRILL GUIDE HANDLE
Published
2019-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844868041030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844868041030008448680410308448680410300844868041030

GMDN Terms

TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)342-54543iPBG-CS@biomet.com

Regulatory Flags

DUNS number
186127825
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00844868051824Single Patient ACT® Twist DrillSPACT20152025-12-18
00844868051831Single Patient ACT® Twist Drill, 2mmD x 10mmLSPACT20102025-12-18
00844868051848Single Patient ACT® Twist DrillSPACT20202025-12-18
00844868051855Single Patient ACT® Twist DrillSPACT206S2025-12-18
00844868051862Single Patient ACT® Twist DrillSPACT27102025-12-18
00844868051879Single Patient ACT® Twist DrillSPACT27152025-12-18
00844868051886Single Patient ACT® Twist DrillSPACT27202025-12-18
00844868051893Single Patient ACT® Twist DrillSPACT30102025-12-18
00844868051909Single Patient ACT® Twist DrillSPACT30152025-12-18
00844868051916Single Patient ACT® Twist DrillSPACT30202025-12-18
00844868051923Single Patient ACT® Twist DrillSPACT31102025-12-18
00844868051930Single Patient ACT® Twist DrillSPACT31152025-12-18
00844868051947Single Patient ACT® Twist DrillSPACT31202025-12-18
00844868051954Single Patient ACT® Twist DrillSPACT32102025-12-18
00844868051961Single Patient ACT® Twist DrillSPACT32152025-12-18
00844868051978Single Patient ACT® Twist DrillSPACT32202025-12-18
00844868051985Single Patient ACT® Twist DrillSPACT326S2025-12-18
00844868051992Single Patient ACT® Twist DrillSPACT38102025-12-18
00844868052005Single Patient ACT® Twist DrillSPACT38152025-12-18
00844868052012Single Patient ACT® Twist DrillSPACT38202025-12-18

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