FDA.reportPublic FDA data

EXEL Dental Needle

Primary DI
30020221265621
Brand
EXEL Dental Needle
Company
Exel International
Model
26562
Catalog number
26562
Device description
30G LONG, 100/BX, 1000/CS, 6CS/CRTN
Published
2019-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K861150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861150000EXEL DENTAL NEEDLEExel Intl.1986-04-11DZM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10020221265627PackageGS1100In Commercial Distribution
20020221265624PackageGS110In Commercial Distribution
30020221265621PackageGS16In Commercial Distribution
00020221265620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002022126562710020221265627
2002022126562420020221265624
3002022126562130020221265621
00020221265620000202212656200202212656200020221265620

GMDN Terms#

Term, Definition table
TermDefinition
Dental syringe needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8009403995info@exelint.com

Regulatory Flags#

DUNS number
180572216
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00020221012156Tandem Diabetes 3mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’100121510012152023-04-17
00020221012163Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’100121610012162023-04-17
000202210605081 mL sterile syringe SNAP26050SNAP26050SNAP2023-04-04
00020221064483EXEL HYPO NDL 28GX3/4" T.W. 2,000/CS, 100PCS/BOX26448B26448B2023-04-06
00020221260175EXEL 0.3mL INS SYR 28GX1/2"26017260172023-03-20
00020221260199EXEL 0.3mL INS SYR 30GX1/2"26019260192023-03-14
00020221260236EXEL 1/2mL INS SYR 28GX1/2"26023260232024-11-25
00020221260243EXEL 1/2mL INS SYR 28GX1/2"26024260242023-03-15
00020221260328EXEL 1/2mL INS 28GX1/2"26032260322023-03-15
00020221260342EXEL 1mL INS 28GX1/2"26034260342023-03-15
00020221260366EXEL U-40 1/2mL INS SYR 29GX1/2"26036260362023-03-15
00020221260373EXEL U-40 1mL INS SYR 29GX1/2"26037260372023-03-15
00020221260380EXEL 1mL AMBER SYR ONLY LUER SLIP W/ TIP CAP26038260382023-03-15
00020221260458EXEL 1ml SYRINGE 26Gx3/8" L-S26045260452023-03-15
00020221260489EXEL Syringes26048260482016-09-20
00020221260519EXEL 1mL TB 21Gx1"-0-DEAD-SPACE26051260512023-03-15
00020221260564EXEL 1ml Syringe 25Gx1" LDS26056260562023-03-15
00020221260571EXEL 1ml Syringe 23Gx1"26057260572023-03-15
00020221260595EXEL 1mL LDS SYR 20G x 1" LUER LOCK26059260592023-03-15
00020221260601EXEL 1mL ALLERGY SYR 27GX1/2", REGULAR BEVEL26060260602023-03-15

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