FDA.report

KLARITY MEDICAL

Primary DI
00817355024113
Brand
KLARITY MEDICAL
Company
KLARITY MEDICAL PRODUCTS, LLC
Model
RNB-10L
Device description
Bitelok® Kit. Includes Bitelok® mouthpiece, QuickFit™ tool, Low Density Putty Packet and IFU.
Published
2019-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817355024113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817355024113008173550241138173550241130817355024113

GMDN Terms

TermDefinition
Head/neck procedure positionerA noninvasive device consisting of fixed or adjustable elements (e.g., frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
034824691
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00840510401108KLARITY MEDICALR7512-70C2026-03-23
00840510401115KLARITY MEDICALR7512-50C2026-03-23
00840510401122KLARITY MEDICALR7512-35C2026-03-23
00840510401139KLARITY MEDICALR7512-47C2026-03-23
00817355025394KLARITY MEDICALR421U2025-10-30
00840510400088KLARITY MEDICALR625-NFCF92026-03-17
00840510401085KLARITY MEDICALKRA3-471122026-03-16
00840510401092KLARITY MEDICALKRA3-36462026-03-16
00817355028111KLARITY MEDICALRE-630ESCF2026-03-13
00817355025806KLARITY MEDICALPS-2022A2026-03-12
00817355025820KLARITY MEDICALPS-3200A2026-03-12
00817355025868KLARITY MEDICALPS-3201A2026-03-12
00817355026247KLARITY MEDICALPS-2400A2026-03-12
00840510401054KLARITY MEDICALGR7504-A30C2026-03-12
00840510401061KLARITY MEDICALRG-BHS-A2436F2026-03-12
00840510401078KLARITY MEDICALRG-BHS-8A24362026-03-12
00817355025622KLARITY MEDICALRE-7EC2022-01-05
00817355021976KLARITY MEDICALP-3201A2026-03-06
00817355025790KLARITY MEDICALPB-2412A2026-03-06
00817355025813KLARITY MEDICALP-3205A2026-03-06

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