FDA.report

AESCULAP

Primary DI
04041906507404
Brand
AESCULAP
Company
Aesculap AG
Model
FX008SU
Catalog number
FX008SU
Device description
TUNNELLER 700MM STANDARD
Published
2023-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GYKInstrument, shunt system implantation

Product Code Classifications

CodeDeviceSpecialtyClass
GYKInstrument, Shunt System ImplantationNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04041906505608PrimaryGS10
04041906507404Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04041906505608040419065056084041906505608
04041906507404040419065074044041906507404

GMDN Terms

TermDefinition
Subcutaneous tunneller, single-useA sterile, hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
10
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
03760124131444SophysaSOPHYSAGYK2023-06-02
13760124131458SophysaSOPHYSAGYK2023-06-02
03760124131468SophysaSOPHYSAGYK2023-06-02
03760124131475SophysaSOPHYSAGYK2023-06-02
04041906507336AESCULAPAesculap AGGYK2023-04-03
04041906507343AESCULAPAesculap AGGYK2023-04-03
04041906507350AESCULAPAesculap AGGYK2023-04-03
04041906507367AESCULAPAesculap AGGYK2023-04-03
04041906507374AESCULAPAesculap AGGYK2023-04-03
04041906507381AESCULAPAesculap AGGYK2023-04-03
04041906507398AESCULAPAesculap AGGYK2023-04-03
00763000031268N/AMEDTRONIC PS MEDICAL, INC.GYK2020-07-20
00382830058193Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
00382830058186Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
10885403070488V. MuellerCAREFUSION 2200, INCGYK2020-04-15
10885403070495V. MuellerCAREFUSION 2200, INCGYK2020-04-15
10885403070501V. MuellerCAREFUSION 2200, INCGYK2020-04-15
00382830057370Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-03
00382830057363Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-03
00382830057509Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-03
00382830057431Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-03
00382830055420Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-03
10381780515487CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
10381780515494CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
10381780515500CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
00381780521399CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
00381780521405CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
00381780521412CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2020-04-01
00763000260019N/AMEDTRONIC PS MEDICAL, INC.GYK2020-03-26
00763000260026N/AMEDTRONIC PS MEDICAL, INC.GYK2020-03-26