FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105202165
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
BS-SP
Device description
Custom Finish (SP-XXXX)
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
MXPBONE PARTICLE COLLECTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXPBone Particle CollectorEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105202165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105202165008401052021658401052021650840105202165

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. 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
08056585230228Micross Curve MaxMETA TECHNOLOGIES SRLMXP2026-03-02
08056585230235Micross Curve MaxMETA TECHNOLOGIES SRLMXP2026-03-02
08800075621580OSUNG MNDOSUNG MND Co., Ltd.MXP2025-11-03
08800075628350OSUNG MNDOSUNG MND Co., Ltd.MXP2025-06-23
08056585230051Micross CurveMETA TECHNOLOGIES SRLMXP2024-11-25
08056585230174Safescraper TwistMETA TECHNOLOGIES SRLMXP2024-11-25
08056585230181Safescraper Twist CurveMETA TECHNOLOGIES SRLMXP2024-11-25
08056585230198Safescraper Twist Curve VolumizerMETA TECHNOLOGIES SRLMXP2024-11-25
08056585230204Micross META TECHNOLOGIES SRLMXP2024-11-25
08056585230211Micross CurveMETA TECHNOLOGIES SRLMXP2024-11-25
00813677023780PDT, Inc.PDT, INC.MXP2024-06-27
00813677024985PDT, Inc.PDT, INC.MXP2024-06-27
08056585230006Safescraper TwistMETA TECHNOLOGIES SRLMXP2024-03-25
08056585230013Safescraper Twist curveMETA TECHNOLOGIES SRLMXP2024-03-25
08056585230020Safescraper Twist curve VolumizerMETA TECHNOLOGIES SRLMXP2024-03-25
08056585230037SmartscraperMETA TECHNOLOGIES SRLMXP2024-03-25
08056585230044MicrossMETA TECHNOLOGIES SRLMXP2024-03-25
08800075604552OSUNG MNDOSUNG MND Co., Ltd.MXP2024-02-26
08800075610973OSUNG MNDOSUNG MND Co., Ltd.MXP2024-02-23
08800075626448OSUNG MNDOSUNG MND Co., Ltd.MXP2024-02-23
08800075622242OSUNG MNDOSUNG MND Co., Ltd.MXP2024-02-22
D92810709510BONE CRUSHER BASEW.H. Holden, Inc.MXP2023-11-05
D92810709520BONE CRUSHER CUPW.H. Holden, Inc.MXP2023-11-05
D92810709530BONE CRUSHER PESTALW.H. Holden, Inc.MXP2023-11-05
D9281072050BONE SCRAPER HANDLE STRAIGHT W/BLADEW.H. Holden, Inc.MXP2023-11-05
D928107205C0BONE SCRAPER HNDLE CURVED W/BLADEW.H. Holden, Inc.MXP2023-11-05
D9281072060BONE SCRAPER REPLMT BLADEW.H. Holden, Inc.MXP2023-11-05
D928107206CSK0REPLCMNT BLADE FOR CRV/STRW.H. Holden, Inc.MXP2023-11-05
D867OSSF0Osseo II Bone TrapXemax Surgical Products IncMXP2023-06-12
00840105222392ZOLL DENTALZoll-DentalMXP2022-03-08