FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653174683
Brand
AESCULAP
Company
Aesculap AG
Model
KY203R
Catalog number
KY203R
Device description
"DEMEL Wire Guide, curved, 12"", (305 mm), blunt, large, 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
04038653174683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653174683040386531746834038653174683

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
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

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
04038653174713AESCULAPAesculap AGHXN2020-04-22
00889024039575Cable-Ready®Zimmer, Inc.HXN2016-07-02
00880304002708BMP CABLE SYSTEMBiomet Orthopedics, LLCHXN2015-10-24
00880304360556BMP CABLE SYSTEMBiomet Orthopedics, LLCHXN2015-10-24