FDA.report

COLUMBUS REVISION

Primary DI
04046963892616
Brand
COLUMBUS REVISION
Company
Aesculap AG
Model
NQ796R
Catalog number
NQ796R
Device description
COLUMBUS REV GUIDE F/FEMUR BOX CHISEL
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KDGCHISEL (OSTEOTOME)

Product Code Classifications

CodeDeviceSpecialtyClass
KDGChisel (Osteotome)General, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046963892616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046963892616040469638926164046963892616

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17
04038653038282AESCULAPDP540RDP540R2020-06-17
04038653038299AESCULAPDP541RDP541R2020-06-17
04038653038305AESCULAPDP542RDP542R2020-06-17
04038653177011AESCULAPOG961ROG961R2016-09-23
04038653251407AESCULAPOG960ROG960R2016-09-23
04038653044207MIASPAS MINI-ALIFFF569RFF569R2020-06-17
04038653044214MIASPAS MINI-ALIFFF571RFF571R2020-06-17
04038653044252MIASPAS MINI-ALIFFF578RFF578R2020-06-17
04038653044283MIASPAS MINI-ALIFFF586RFF586R2020-06-17
04038653117307AESCULAPNH196NH1962017-01-27
04038653117352AESCULAPNH206NH2062017-01-27
04038653118540AESCULAPNK088NK0882015-11-11
04038653118557AESCULAPNK089NK0892015-09-24
04038653118564AESCULAPNK090NK0902015-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B382SD914459320Surgical DirectSurgical Direct, Inc.KDG2026-02-25
B382SD914031000Surgical DirectSurgical Direct, Inc.KDG2026-02-20
B382SD914031010Surgical DirectSurgical Direct, Inc.KDG2026-02-20
B382SD914456290Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663010Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663020Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663030Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663040Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD914591000Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD921648100Surgical DirectSurgical Direct, Inc.KDG2026-02-09
00810158218635PRINCETONPrinceton Medical Group, Inc.KDG2026-01-20
00810158218734PRINCETONPrinceton Medical Group, Inc.KDG2026-01-20
00810158218499PRINCETONPrinceton Medical Group, Inc.KDG2026-01-15
00810158218536PRINCETONPrinceton Medical Group, Inc.KDG2026-01-15
B382SD48820520Surgical DirectSurgical Direct, Inc.KDG2025-12-02
00810158218086PRINCETONPrinceton Medical Group, Inc.KDG2025-11-24
00810158217393PRINCETONPrinceton Medical Group, Inc.KDG2025-09-29
B382SD9219563010Surgical DirectSurgical Direct, Inc.KDG2025-09-22
B382SD936682100Surgical DirectSurgical Direct, Inc.KDG2025-09-18
B382SD9146891000Surgical DirectSurgical Direct, Inc.KDG2025-09-12
00810158216471PRINCETONPrinceton Medical Group, Inc.KDG2025-08-21
00810158215894PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216044PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216051PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216068PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216075PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216082PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
B382SD921381020Surgical DirectSurgical Direct, Inc.KDG2025-08-11
B382SD921646030Surgical DirectSurgical Direct, Inc.KDG2025-08-11
B382SD921646040Surgical DirectSurgical Direct, Inc.KDG2025-08-11