FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653174713
Brand
AESCULAP
Company
Aesculap AG
Model
KY206R
Catalog number
KY206R
Device description
"Wire Guide, curved, 10 3/4"", (275 mm), non-sterile, reusable"
Published
2020-04-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXNAPPLIER, CERCLAGE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXNApplier, CerclageOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653174713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653174713040386531747134038653174713

GMDN Terms#

Term, Definition table
TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
315018218
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03613720286783LIGAPASSMEDICREA INTERNATIONALHXN2021-05-25
00191083003931EVOS Cabling SystemPioneer Surgical Technology, Inc.HXN2021-02-01
00191083003948EVOS Cabling SystemPioneer Surgical Technology, Inc.HXN2021-02-01
00191083003986EVOS Cabling SystemPioneer Surgical Technology, Inc.HXN2021-02-01
00191083003993EVOS Cabling SystemPioneer Surgical Technology, Inc.HXN2021-02-01
04038653174676AESCULAPAesculap AGHXN2020-04-22
04038653174683AESCULAPAesculap AGHXN2020-04-22
00889024039575Cable-Ready®Zimmer, Inc.HXN2016-07-02
00880304002708BMP CABLE SYSTEMBiomet Orthopedics, LLCHXN2015-10-24
00880304360556BMP CABLE SYSTEMBiomet Orthopedics, LLCHXN2015-10-24