Premier

Primary DI
D6919048699
Brand
Premier
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9048699
Device description
SAMPLE – Retraction Caps – 3 - #5, 1 - #3, 1 - #1
Published
2022-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NYFGingival Retraction Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYFGingival Retraction KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6919048699PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction cord, non-medicatedA non-medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
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
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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00348783003611Premier Retraction CapPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783003628Premier Retraction CapPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783003635Premier Retraction CapPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
00348783003642Premier Retraction CapPREMIER DENTAL PRODUCTS COMPANYNYF2022-06-29
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