FDA.reportPublic FDA data

Unipack

Primary DI
40665973030461
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
UMT-9024
Catalog number
UMT-9024
Device description
Core Oral Tips Long
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJBHANDLE, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40665973030461PackageGS110In Commercial Distribution
10665973030460PrimaryGS10
00665973030463Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4066597303046140665973030461
1066597303046010665973030460
00665973030463006659730304636659730304630665973030463

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
018319397
Device count
25
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10665973029839UnipackUGC-6610-LUGC-6610-L2022-12-06
10665973029846UnipackUGC-6610-MUGC-6610-M2022-12-06
10665973029853UnipackUGC-6610-SUGC-6610-S2022-12-06
10665973029860UnipackUGC-6610-XLUGC-6610-XL2022-12-06
10665973029877UnipackUGC-6610-XXLUGC-6610-XXL2022-12-06
10665973030347UnipackUGJ-6510-LUGJ-6510-L2022-12-06
10665973030354UnipackUGJ-6510-MUGJ-6510-M2022-12-06
10665973030361UnipackUGJ-6510-SUGJ-6510-S2022-12-06
10665973030378UnipackUGJ-6510-XLUGJ-6510-XL2022-12-06
10665973030385UnipackUGJ-6510-XXLUGJ-6510-XXL2022-12-06
10850008682237UnipackUMA-9121-FUMA-9121-F2022-12-07
10850008682244UnipackUMA-9122-RUMA-9122-R2022-12-07
10850008682251UnipackUMA-9123-AUMA-9123-A2022-12-07
D784UBC8010E5UnipackUBC-8010EUBC-8010E2022-12-07
D784UBC8011A5UnipackUBC-8011AUBC-8011A2022-12-07
D784UBC8012B5UnipackUBC-8012BUBC-8012B2022-12-07
D784UBC8013F5UnipackUBC-8013FUBC-8013F2022-12-07
D784UBC80235UnipackUBC-8023UBC-80232022-12-07
D784UBC80245UnipackUBC-8024UBC-80242022-12-07
D784UBC80255UnipackUBC-8025UBC-80252022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71050TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71060TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71070TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71080TBS BASICSACME ENTERPRISE.EJB2026-05-22
00348783010206Premier Mirror HandlesPREMIER DENTAL PRODUCTS COMPANYEJB2026-03-17
G1493807306TBS DentalACME ENTERPRISE.EJB2026-03-02
00841013120459Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
00841013120466Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
30371347019668Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019675Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019682Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019699Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017724Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017748Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00883205032164Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-21
00883205032157Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-19
08806343925183ever KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925213TAPER KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925220GUIDE KITShinhung MST Co., Ltd.EJB2025-07-28
08057639710567Specialist OrganizerMC BIO SRLEJB2025-06-23
08057639710574Tip with Indexable StopMC BIO SRLEJB2025-06-23
08057639710598Offset Tip SPMC BIO SRLEJB2025-06-23
08057639710604Long Tip SPMC BIO SRLEJB2025-06-23
08057639710628GBR MODULAR SETMC BIO SRLEJB2025-06-23
08057639712066Handle - Straight MDFMC BIO SRLEJB2025-06-23
08057639712073Handle - Straight - ErgalMC BIO SRLEJB2025-06-23
08057639712080Handle - Straight SP (TiN)MC BIO SRLEJB2025-06-23
08057639712097Handle - Asym. - ErgalMC BIO SRLEJB2025-06-23
08057639712103Handle - Asym. - SP (TiN)MC BIO SRLEJB2025-06-23
08057639712110Handle - Asym. - TitaniumMC BIO SRLEJB2025-06-23