FDA.report

easy impression syringe blue

Primary DI
EDET021401
Brand
easy impression syringe blue
Company
DETAX GmbH & Co. KG
Model
02140
Published
2022-10-14
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
KCPSyringe, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EDET021401PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental impression material syringe, reusableA non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
317099257
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
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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EDET029481protect mold neon orange 2 x 100ml029482022-10-25
EDET029491super coat 100ml029492022-10-25
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EDET030151dip coat 250ml030152022-10-25
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