FDA.report

AESCULAP

Primary DI
04038653045167
Brand
AESCULAP
Company
Aesculap AG
Model
FK291R
Catalog number
FK291R
Device description
MAC DONALD Dissector, curved, 7 1/4", (185 mm), double ended, blunt/blunt, non-sterile, reusable
Published
2020-04-20
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
GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653045167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653045167040386530451674038653045167

GMDN Terms

TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+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
07898789390015TREPSAT FACELIFT DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-23
00192896122888DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122895Ball DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122901Hook DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122918Hook DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122925Spatula DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122932Spatula DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
09348811151254INKAThe Trustee for KAISER FAMILY TRUSTGDI2026-03-16
00192896122703Ochsner DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-10
00840180544778General InstrumentsALPHATEC SPINE, INC.GDI2026-01-29
00840180544525General InstrumentsALPHATEC SPINE, INC.GDI2025-12-31
08809407604543DissectorHankil Tech Medical Co., Ltd.GDI2025-12-16
00196449034536Anatomic Access LLIFTyber Medical, LLCGDI2025-12-02
09348811025494INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
09348811025500INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
09348811146663INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
03662663276849Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-17
00757770701209Bausch + LombBausch & Lomb IncorporatedGDI2025-11-16
03662663267236Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
03662663267243Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
03662663267250Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
00757770676354Bausch + LombBausch & Lomb IncorporatedGDI2025-11-14
00757770688517Bausch + LombBausch & Lomb IncorporatedGDI2025-11-14
03662663131308Disc Preparation InstrumentsHighridge Medical, LLCGDI2025-11-14
03662663192835Breckenridge ACDF SystemHighridge Medical, LLCGDI2025-11-14
00196449034529Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
00763000936440NAMEDTRONIC, INC.GDI2025-09-29
00192896122116Ball ProbeSONTEC INSTRUMENTS, INC.GDI2025-09-26
16971503601937comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
16971503601944comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28