FDA.report

Micro Capillary Tip

Primary DI
00883205022011
Brand
Micro Capillary Tip
Company
ULTRADENT PRODUCTS, INC.
Model
1121
Catalog number
1121
Device description
Micro Capillary Tips, 10mm 20pk
Published
2018-04-28
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

Related Records

Contact Domains

Product Codes

CodeName
EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Product Code Classifications

CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00883205022011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205022011008832050220118832050220110883205022011

GMDN Terms

TermDefinition
Syringe tip capA device intended to cover the tip of a syringe (without a needle) in order to prevent the leakage of syringe contents and to maintain content sterility until the syringe is used. This device is typically constructed of plastic. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags

DUNS number
013369913
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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00850440008551JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008568JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008575JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
008504400086433DPD Paste Delivery TipEngineered Endodontics, LLCEIC2026-01-02
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