FDA.report

NAVIGATOR® CERTAIN®

Primary DI
00844868021803
Brand
NAVIGATOR® CERTAIN®
Company
BIOMET 3I, LLC
Model
SGIAM5S
Device description
NAVIGATOR® CERTAIN® ANALOG MOUNT 5MM(D) SHORT
Published
2016-04-22
Public version status
Update
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
00844868021803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844868021803008448680218038448680218030844868021803

GMDN Terms

TermDefinition
Orthopaedic implant/trial-implant holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft) or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

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

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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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