FDA.report

Health-Tec/DHP Syringes with Needle

Primary DI
D773130100061
Brand
Health-Tec/DHP Syringes with Needle
Company
Dental Health Products Inc
Model
130-10006
Catalog number
130-10006
Device description
Health-Tec/DHP Luer Lock Syringes 3cc with 23ga Irrigation Needle 100/box
Published
2022-10-19
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

Product Codes

CodeName
EICSyringe, Periodontic, Endodontic, Irrigating

Product Code Classifications

CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D773130100061PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental delivery system irrigation handpiece tipA rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
623191194
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
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

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D7736001000320DHP/Health-Tec Sterilization Pouches600-100032600-1000322023-03-23
D7736001000420DHP/Health-Tec Sterilization Pouches600-100042600-1000422023-03-23
D7736001000520DHP/Health-Tec Sterilization Pouches600-100052600-1000522023-03-23
D7736001000620DHP/Health-Tec Sterilization Pouches600-100062600-1000622023-03-23
D7736001000720DHP/Health-Tec Sterilization Pouches600-100072600-1000722023-03-23
D7736001000820DHP/Health-Tec Sterilization Pouches600-100082600-1000822023-03-23
D7736001000920DHP/Health-Tec Sterilization Pouches600-100092600-1000922023-03-23
D7736001001020DHP/Health-Tec Sterilization Pouches600-100102600-1001022023-03-23
D7736001001120DHP/Health-Tec Sterilization Pouches600-100112600-1001122023-03-23
D773970100010Health-Tec/DHP Disposable Prophy Angles970-10001970-100012022-11-28
D773970100020Health-Tec/DHP Disposable Prophy Angles970-10002970-100022022-11-28
D7739705220140Health-Tec/DHP Disposable Prophy Angles970-522014970-5220142022-11-28
D773970522140Health-Tec/DHP Disposable Prophy Angles970-522114970-5221142022-11-28
D7739705224140Health-Tec/DHP Disposable Prophy Angles970-522414970-5224142022-11-28
D7739705225140Health-Tec/DHP Disposable Prophy Angles970-522514970-5225142022-11-28
D773930100060Health-Tec/DHP PSP Barrier Envelopes930-10006930-100062022-11-14
D773930HTBWT0Health-Tec/DHP Bite Wing Tabs930-HTBWT930-HTBWT2022-11-14
D773800100020Health-Tec/DHP Matrix Bands800-10002800-100022022-11-10

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