FDA.report

Uni-Wedge, Narrow, Green (250)

Primary DI
D248938540
Brand
Uni-Wedge, Narrow, Green (250)
Company
HAGER WORLDWIDE, INC.
Model
93854
Device description
Uni-Wedge, Narrow, Green (250)
Published
2023-05-15
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
false

Related Records

Contact Domains

Product Codes

CodeName
EIFACCESSORIES, RETRACTOR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D248938540PrimaryHIBCC0
D248938541Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental wedge, single-useA dental device that is positioned wedge-like at the interdental and cervical area of the teeth during routine intraoral dental procedures. It is used to slightly separate the teeth during the placement of a filling material, or to stabilize and support other devices, e.g., a matrix band or a rubber dam. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
009277971
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

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D248222300SafeDispense - Silver222302024-04-12
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