FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105200734
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
BS-ST2
Device description
BS-ST2 Bone Scraper
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

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
00840105200734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105200734008401052007348401052007340840105200734

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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056585230228Micross Curve MaxMETA TECHNOLOGIES SRLMXP2026-03-02
08056585230235Micross Curve MaxMETA TECHNOLOGIES SRLMXP2026-03-02
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
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
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
00840105200727ZOLL-DENTALZoll-DentalMXP2021-03-10
00840105200741ZOLL-DENTALZoll-DentalMXP2021-03-10
00840105202165ZOLL-DENTALZoll-DentalMXP2021-03-10