FDA.reportPublic FDA data

BONE CRUSHER CUP

Primary DI
D92810709520
Brand
BONE CRUSHER CUP
Company
W.H. Holden, Inc.
Model
10-7095-2
Published
2023-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D92810709520PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
183854322
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D928105406HFDLC0STAHR TUNNEL RETRACTOR HF D/E DLC10-5406HFDLC2026-03-18
D928105535DLC0"""OH"" ZYGOMA RETRACTOR DLC"10-5535DLC2026-03-18
D9284004001CH0PERIO FILE SUGARMAN 1S D/E CH HANDLE SPECIAL DR SIN40-0400-1CH2026-03-18
D9284004002CH0PERIO FILE SUGARMAN 2S D/E CH HANDLE SPECIAL DR SIN40-0400-2CH2026-03-18
D928400400CH0PERIO FILE SUGARMAN 1S/2S D/E CH HANDLE40-0400CH2026-03-18
D928400400HD0PERIO FILE SUGARMAN 1S/2S D/E HD HANDLE40-0400HD2026-03-18
D928400400HF0PERIO FILE SUGARMAN 1S/2S D/E HF HANDLE40-0400HF2026-03-18
D928400435RD0PERIO FILE SCHLUGER 9/10 D/E ROUND HANDLE40-0435RD2026-03-18
D9281051992HF0SINUS INSTRUMENT #2 HF D/E10-5199-2HF2026-02-19
D928400527H0POWERTOME S/E HF HANDLE40-0527H2026-01-27
D928106122R450SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLE10-6122-R452026-01-15
D9281059552HF570CURETTE SINUS LARGE PADDLE SHARP, SMALL PADDLE DULL, D/E HANDFORM HANDLE LONG10-5955-2HF572026-01-14
D928400101CH0PERIO KNIFE GOLDMAN FOX 8 CH HANDLE40-0101CH2026-01-14
D928400102CH0PERIO KNIFE GOLDMAN FOX 11 CH HANDLE40-0102CH2026-01-14
D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLE40-0102HF2026-01-14
D928400102R0PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLE40-0102R2026-01-14
D9284001040D928400104040-01042026-01-14
D928100600962DLC0EXTRACTION FORCEPS #962 UPPER DLC10-0600-962DLC2026-01-06
D9281009301850RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MM10-0930-18-52026-01-06
D9281009302390RONGEUR DOUBLE ACTION RUSKIN CURVED 23CM, 6MM10-0930-23-62026-01-06

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
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