FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105211891
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
RT-HB17/18
Device description
Heidbrink #17/18
Published
2021-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105211891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105211891008401052118918401052118910840105211891

GMDN Terms#

Term, Definition table
TermDefinition
Dental elevator, tooth/rootA hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(847)647-1819JEFF@ZOLLDENTAL.COM

Regulatory Flags#

DUNS number
005449822
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840105223009ZOLL DENTALSYR-4962-22023-07-11
00840105223818ZOLL DENTALZ-49342025-09-16
00840105223825ZOLL DENTALZ-49362025-09-16
00840105223832ZOLL DENTALZ-49372025-09-16
00840105223801ZOLL DENTALZ-49352025-08-11
00840105223757ZOLL DENTALGK-TUN-K62025-08-06
00840105223764ZOLL DENTALGK-TUN-K72025-08-06
00840105223771ZOLL DENTALGK-TUN-K82025-08-06
00840105223788ZOLL DENTALGK-TUN-K92025-08-06
00840105223795ZOLL DENTALGK-TUN-K102025-08-06
00840105223740ZOLL DENTALZ-99972025-07-24
00840105215226ZOLL-DENTALZ-10TKP2021-03-10
00840105215714ZOLL-DENTALZ-11TKP2021-03-10
00840105215967ZOLL-DENTALZ-12TKP2021-03-10
00840105216131ZOLL-DENTALZ-19-274-13-P2021-03-10
00840105216148ZOLL-DENTALZ-19-274-13-T2021-03-10
00840105216155ZOLL-DENTALZ-19-274-162021-03-10
00840105218388ZOLL-DENTALZ-44382021-03-10
00840105220268ZOLL-DENTALZ-71451-002021-03-10
00840105220275ZOLL-DENTALZ-71451-012021-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD6216030Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD6216060Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD6216080Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD907037100T0Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD9070451100Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD907075030Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD92268003T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268030T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268031T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268032T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268033T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268034T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268035T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268036T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268037T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268038T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268039T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268040T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268041T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268042T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268043T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268044T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268045T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268046T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268047T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268048T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD9147091800Surgical DirectSurgical Direct, Inc.GEG2026-07-09
00850083275822Intrace USAPILOTIS TECH LLCGEG2026-07-03
00850083275853Intrace USAPILOTIS TECH LLCGEG2026-07-03
008401944957383P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GEG2026-06-10