FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105217459
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
Z-4097
Device description
Crane-Kaplan Marking Forceps Right
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
EMPMARKER, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMPMarker, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105217459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105217459008401052174598401052174590840105217459

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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
04251436943805KOHLERKohler Medizintechnik GmbHEMP2026-03-12
00841336108622Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMP2025-11-11
00860012076604UMarcNew Venture Enterprise Ltd.EMP2024-07-03
00860012076611UMarcNew Venture Enterprise Ltd.EMP2024-07-03
10860012076601UMarcNew Venture Enterprise Ltd.EMP2024-07-03
20860012076615UMarcNew Venture Enterprise Ltd.EMP2024-07-03
00841336101760Salvin Stainless Steel UNC ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-08-21
00841336105430Perio Probe BlackSALVIN DENTAL SPECIALTIES, LLCEMP2023-08-10
00841336101791Salvin Titanium CP12 Perio ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-07-31
00841336101807Salvin Titanium UNC-15 Perio ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-07-31
10889950086527Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMP2023-04-07
00887919771371Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771432Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771463Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771494Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
04251436904646KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436904936KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905032KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905049KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905056KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905063KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436925818KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436925856KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436930621KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436931253KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436931260KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436933141KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
00840105217442ZOLL-DENTALZoll-DentalEMP2021-03-10
10381780450283Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEMP2018-02-26
10381780450290Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEMP2018-02-26