Who else makes this device?

Name: Sheehy Bone Dust Collector
Brand: Sheehy Bone Dust Collector

Ear Nose & Throat › SurgicalBone Particle Collector

Sheehy Bone Dust Collector

Catalogue number S-2500, listed by Oto Med Inc, under Bone Particle Collector. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

3recalls on this code

Who Else Makes It

All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MXP
Manufacturer	City	Province	Registered as	Device types
Shenzhen Denco Medical Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	52
Shenzhen Rogin Medical Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	51

Record

Regulatory record for Sheehy Bone Dust Collector
Listed by	Oto Med Inc
FDA product code	MXP
Device type	Bone Particle Collector
Device class	Class 1
Regulation	21 CFR 874.4800
Premarket notification	Exempt
Record published	2018-09-21
Record revised	2020-12-21 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Sheehy Bone Dust Collector
Catalogue number	Size	Status
S-2500		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Zoll Dental	Zoll-Dental	14
Osung MND	Osung MND Co., Ltd.	6
Safescraper Twist Curve Volumizer	Meta Health, Inc.	2
Micross	Meta Health, Inc.	2
Exmoor	Exmoor Plastics Limited	2
Safescraper Twist Curve	Meta Health, Inc.	2
Micross Curve	Meta Health, Inc.	2
Micross Curve Max	Meta Health, Inc.	2
Safescraper Twist	Meta Health, Inc.	2
PDT, Inc.	PDT, Inc.	1
Bone Crusher Base	W.H. Holden, Inc.	1
Bone Crusher CUP	W.H. Holden, Inc.	1

Showing 12 of 23. All products under Bone Particle Collector

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Sheehy Bone Dust Collector
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Oto Med Inc	UDI-DI	2020-12-07	Class II	Package design/selection	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.	13,335 devices

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2020-12-07	Class II	Package design/selection	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.	5,092 devices
2020-12-07	Class II	Package design/selection	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.	415 devices

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.