FDA.reportPublic FDA data

SHEEHY BONE DUST COLLECTOR

Primary DI
00850000126046
Brand
SHEEHY BONE DUST COLLECTOR
Company
Oto-Med, Inc.
Model
S-2500
Device description
SHEEHY BONE DUST COLLECTOR
Published
2018-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
00850000126046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000126046008500001260468500001260460850000126046

GMDN Terms#

Term, Definition table
TermDefinition
Otological bone particle collectorA filtering device designed to be placed into an otological surgical tube to collect bone fragments. It is intended to save bone particles during the first stage of middle ear surgery for future use. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)472-2363info@gracemedical.com

Regulatory Flags#

DUNS number
059817742
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000126077spineX BONE DUST COLLECTORS-45002018-09-21
00850000126169CI UNIVERSAL DRAPESD-23002021-11-19
00850000126084GLASSCOCK OTOLOGY SURGERY DRAPESD-21002018-09-21
00850000126091GLASSCOCK NEUROTOLOGY SURGERY DRAPESD-22002018-09-21
10850000126166CI UNIVERSAL DRAPESD-23002021-11-19
00850000126121OTOMED® SUCTION TUBINGSP-40002018-09-21
00850000126152LEVINE IRRIGATION-SUCTION TUBINGSP-30002021-01-29
10850000126159LEVINE IRRIGATION-SUCTION TUBINGSP-30002021-01-29
00850000126015GLASSCOCK® EAR DRESSING, ADULTS-10002018-09-21
00850000126022GLASSCOCK® EAR DRESSING, PEDIATRICS-10032018-09-21
00850000126060COX BONE DUST COLLECTORS-35002018-09-21
00850000126138EAR DRESSING, ADULTS-10002020-11-30
00850000126145EAR DRESSING, PEDIATRICS-10032020-11-30
10850000126135EAR DRESSING, ADULTS-10002020-11-30
10850000126142EAR DRESSING, PEDIATRICS-10032020-11-30
00850000126039HEAD & NECK PRESSURE DRESSINGS-1010-22018-09-21
00850000126114LEVINE IRRIGATION-SUCTION KITSP-30002018-09-21
00850000126053SHEEHY-HOUSE POWDER INSUFFLATORS-30012018-09-21
00850000126107SAFETRAP TISSUE COLLECTORSP-20002018-09-21

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