FDA.report

Soft Lining Trimmer Probe

Primary DI
D248637010
Brand
Soft Lining Trimmer Probe
Company
HAGER WORLDWIDE, INC.
Model
63701
Device description
Soft Lining Trimmer Probe
Published
2023-05-12
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

Product Codes

CodeName
EIKCARVER, WAX, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D248637010PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental wax carverA hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. This is a reusable 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
true
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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