FDA.report

ZOLL-DENTAL

Primary DI
00840105217237
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
Z-4063
Device description
Needle Holder, Castroviejo Flat Body Straight TC 18cm
Published
2021-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HXKHOLDER, NEEDLE; ORTHOPEDIC

Product Code Classifications

CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840105217237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105217237008401052172378401052172370840105217237

GMDN Terms

TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(847)647-1819JEFF@ZOLLDENTAL.COM

Regulatory Flags

DUNS number
005449822
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00840105223733ZOLLDENTALS-ST22025-03-17
00840105223726ZOLL DENTALZ-73012025-01-29
00840105223672ZOLL DENTALZ-13022024-12-18
00840105223689ZOLL DENTALZ-13032024-12-18
00840105223696ZOLL DENTALZ-47862024-12-18
00840105223702ZOLL DENTALZ-47872024-12-18
00840105223719ZOLL DENTALZ-47902024-12-18
00840105223658ZOLL DENTALZ-52585052024-12-11
00840105223665ZOLL DENTALZ-48205052024-12-11
00840105223641ZOLL DENTALZ-49862024-08-26
00840105223634ZOLL DENTALRET-UofMN-BENT2024-08-01
00840105223573ZOLL DENTALZ-49332024-07-29
00840105223597ZOLL DENTALZ-90322024-07-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810158219335PRINCETONPrinceton Medical Group, Inc.HXK2026-03-12
00810158219113PRINCETONPrinceton Medical Group, Inc.HXK2026-03-11
04058749027327NAFehling Instruments GmbH & Co. KGHXK2026-03-05
04058749027457NAFehling Instruments GmbH & Co. KGHXK2026-03-05
04058749028102NAFehling Instruments GmbH & Co. KGHXK2026-03-05
00810158218772PRINCETONPrinceton Medical Group, Inc.HXK2026-02-05
00810158218819PRINCETONPrinceton Medical Group, Inc.HXK2026-02-05
B356DF370170American MedicalsAmerican MedicalsHXK2026-01-30
04058749027990NAFehling Instruments GmbH & Co. KGHXK2026-01-28
04058749028003NAFehling Instruments GmbH & Co. KGHXK2026-01-28
00840217910125Wiggins medicalEbner Medical, LLCHXK2025-12-10
00840217910163Wiggins medicalEbner Medical, LLCHXK2025-12-10
04058749026764NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749027471NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749027495NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749119695NAFehling Instruments GmbH & Co. KGHXK2025-12-08
09348811016287INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-12-02
00757770676446Bausch + LombBausch & Lomb IncorporatedHXK2025-11-14
00841336107632Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHXK2025-09-28
00840314270078gSourceGSOURCE LLCHXK2025-09-21
00810158217065PRINCETONPrinceton Medical Group, Inc.HXK2025-09-18
00810158216792PRINCETONPrinceton Medical Group, Inc.HXK2025-09-02
04058749028232NAFehling Instruments GmbH & Co. KGHXK2025-09-01
04058749026771NAFehling Instruments GmbH & Co. KGHXK2025-08-29
00840217909822Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909839Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909853Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909860Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909884Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909907Wiggins medicalEbner Medical, LLCHXK2025-08-20