FDA.reportPublic FDA data

Monoject

Primary DI
20884521002804
Brand
Monoject
Company
Cardinal Health, Inc.
Model
8881401049
Catalog number
8881401049
Device description
Dental Needle,Metal Hub,25 G Short
Published
2018-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZMNEEDLE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521002804PackageGS11000In Commercial Distribution
10884521002807PrimaryGS10
30884521002801Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100280420884521002804
1088452100280710884521002807
3088452100280130884521002801

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length1Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
Device count
100
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
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
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053610773750EFFITECDENTALHITECDZM2026-08-06
08053610773781EFFITECTECNOFAR SPADZM2026-07-30
08053610773798EFFITECTECNOFAR SPADZM2026-07-30
08053610773804EFFITECTECNOFAR SPADZM2026-07-30
06973042242834Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242841Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242865Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242872Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242889Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242896Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242902Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242919Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242926Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242933Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
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06973042242964Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242971Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242988Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242674Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242681Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242698Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242704Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242711Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242728Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242735Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242742Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242759Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242766Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242780Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09