FDA.report

BIO VACUUM TIP - SHORT

Primary DI
D248254010
Brand
BIO VACUUM TIP - SHORT
Company
HAGER WORLDWIDE, INC.
Model
254011
Device description
Dental evacuation tip, 95mm, bio-based material
Published
2023-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DYNMouthpiece, saliva ejector

Product Code Classifications

CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D2482540111PrimaryHIBCC0
D248254010Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental suction system cannula, reusableA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(828)624-3319d.pritchard@hagerworldwide.com

Regulatory Flags

DUNS number
009277971
Device count
100
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07615208543506Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
D9099002011ORTHO ARCHOrtho Arch Company IncDYN2025-09-15
00840456209158JMUJMU DENTAL, INCDYN2025-06-17
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00860349001737SWIK Modular Extension TubingSaliva Management Systems, Inc.DYN2025-06-17
00840161310668Pink Petal™ - Saliva Ejector Holder - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2025-01-09
50732224005008Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224004988Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224005015Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224005022Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
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