FDA.reportPublic FDA data

Arthrex

Primary DI
B504OMAR6527190
Brand
Arthrex
Company
Provision
Model
AR-6527-19
Published
2021-08-05
Public version status
New
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
GESBlade, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B504OMAR6527190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, reciprocating, reprocessedA flat surgical cutting instrument with a serrated edge, designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (not a dedicated sternum saw blade). It is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device that has previously been used on a patient and has been reprocessed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
541-480-7953customersupport@provisiondrs.com

Regulatory Flags#

DUNS number
016889401
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B504OM4515700130DePuy Mitek4515700132026-03-19
B504OM50715940Conmed Linvatec5071-5942026-03-19
B504OMDC119090180Conmed LinvatecDC119-090-182026-03-19
B504OM50711330ConMed Linvatec5071-1332026-02-24
B504OM50721010ConMed Linvatec5072-1012026-02-24
B504OMBR58201070250BrasselerBR5820-107-0252026-02-24
B504OMPDS2NL300NakanishiPDS-2NL-302026-02-09
B504OM13090119XG10Zimmer13090119XG12025-11-25
B504OM19100119XG10Zimmer19100119XG12025-11-25
B504OM20090119XC10Zimmer20090119XC12025-11-25
B504OM20100119XC10Zimmer20100119XC12025-11-25
B504OM20100119XCW0Zimmer20100119XCW2025-11-25
B504OM21090119XGW0Zimmer21090119XGW2025-11-25
B504AE2273010DePuy Mitek 2273012018-04-05
B504AE2273020DePuy Mitek 2273022018-04-05
B504AE2273050DePuy Mitek 2273052018-04-05
B504CBEICA5874010Smith & NephewEICA5874-012018-04-03
B504CBEICA8875010Smith & NephewEICA8875-012018-04-03
B504CBEICA8898010Smith & NephewEICA8898-012018-04-03
B504EICA9820010Smith & NephewEICA9820-012019-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459343513MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GES2025-05-22
08717903490228Humeca blade for Silver knifeHumeca B.V.GES2025-05-20
08717903490242Humeca blade for Humby long knife (20cm/7.9 in)Humeca B.V.GES2025-05-20
08717903490235Humeca blade for Humby, Cobbett and Watson knives (16 cm/6.3 in)Humeca B.V.GES2025-05-19
10888277384224MEDLINEMEDLINE INDUSTRIES, INC.GES2025-02-14
10888277391857MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-30
10888277383395MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10888277385115MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10850053289818SurgycoSurgyco LLCGES2024-12-20
10850053289825SurgycoSurgyco LLCGES2024-12-20
10850053289832SurgycoSurgyco LLCGES2024-12-20
10850053289849SurgycoSurgyco LLCGES2024-12-20
10850053289856SurgycoSurgyco LLCGES2024-12-20
08902895180190KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180206KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180213KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180220KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180237KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
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08902895180275KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180282KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180299KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180305KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180336KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182101KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182125KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182156KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182200KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182217KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06