FDA.reportPublic FDA data

Capseus Surgical

Primary DI
30665973027112
Brand
Capseus Surgical
Company
DUKAL CORPORATION
Model
BDC-15
Catalog number
BDC-15
Device description
Bone Dust Collector - 9646
Published
2019-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20665973027115PackageGS15In Commercial Distribution
30665973027112PackageGS14In Commercial Distribution
10665973027118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2066597302711520665973027115
3066597302711230665973027112
1066597302711810665973027118

GMDN Terms#

Term, Definition table
TermDefinition
Bone dust vacuum systemAn assembly of devices used to collect bone dust from the workspace environment by suction, typically during autopsy sawing procedures. It generally consists of a mains electricity (AC-powered) vacuum motor, tubing, collection container, and a filter. The proximal end of the vacuum tubing will typically attach to the saw, and the vacuum motor may automatically run concurrently with the saw motor.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
791014871
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20665973027146Dukal27301273012022-03-30
20665973027153Dukal27302273022022-03-30
20665973027160Dukal27303273032022-03-30
20665973027177Dukal27304273042022-03-30
20665973027184Dukal27305273052022-03-30
20665973027191Dukal27306273062022-03-30
20665973027207Dukal27307273072022-03-30
20665973028891Dukal158015802022-03-30
00665973027173Dukal27304-BK27304-BK2022-03-30
20665973028099DukalAB100AB1002022-03-28
60665973010375DukalCM-101CM-1012020-10-14
20665973004970Dukal154015402016-09-24
20665973004987Dukal155015502016-09-24
20665973004994Dukal156015602016-09-24
20665973005557Dukal154115412016-09-24
20665973005564Dukal154215422016-09-24
20665973017765Derma Science17240172402016-12-02
20665973016775Tech-Med601260122016-09-24
20665973016782Tech-Med601060102016-09-24
20665973016799Tech-Med6010-T6010-T2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956375642CARDINAL HEALTHCardinal Health 200, LLCGCX2026-02-13
10198956277939CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-22
10198956289284CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-12
10198956261808CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-17
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10192253043389CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043396CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043402CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043419CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10198956252127CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-25
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
10198956241909CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-04
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10198459423567MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GCX2025-07-21
10198459398063MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GCX2025-07-07
10198956073883CARDINAL HEALTHCardinal Health 200, LLCGCX2025-07-04
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08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
10198956013704CARDINAL HEALTHCardinal Health 200, LLCGCX2025-05-09
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08