FDA.reportPublic FDA data

Sophysa

Primary DI
13760124131458
Brand
Sophysa
Company
SOPHYSA
Model
TUG-65
Device description
DISPOSABLE TUBUAR SHEATH FOR CATHETER PASSER 65 CM
Published
2023-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GYKInstrument, Shunt System Implantation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYKInstrument, Shunt System ImplantationNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760124131451PrimaryGS10
13760124131458Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760124131451037601241314513760124131451
1376012413145813760124131458

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
262951353
Device count
25
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760124131703SophysaSPV-SX2015-10-16
03760409446294Phoenix NeuroFVPC42025-12-24
03760124134315Phoenix NeuroFVPC42015-10-16
03760124132908SophysaPSO-PBT2024-03-26
03760124132915SophysaPSO-PTT2024-03-26
03760124132922SophysaPSO-VTT2024-03-26
03760124131451SophysaTUG-652023-06-02
03760124133813Phoenix NeuroSP052015-10-16
03760124134803Phoenix NeuroSP032015-10-16
03760124134810Phoenix NeuroSP042015-10-16
03760124131444SophysaTUG-452023-06-02
03760124131468SophysaTUN-452023-06-02
03760124131475SophysaTUN-652023-06-02
03760124130744SOPHYSAPSO-MC062016-07-20
03760124130751SOPHYSAPSO-MC072016-07-20
03760124131635SOPHYSAPSO-MC102016-07-20
03760124132106SophysaPAK24-SI2017-03-30
03760124130577SophysaPRO92015-10-16
03760124130584SophysaPRO102015-10-16
03760124130591SophysaPRO112015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780537397CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2024-05-29
10381780537403CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2024-05-29
10381780537410CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2024-05-29
03760124131451SophysaSOPHYSAGYK2023-06-02
03760124131444SophysaSOPHYSAGYK2023-06-02
03760124131468SophysaSOPHYSAGYK2023-06-02
03760124131475SophysaSOPHYSAGYK2023-06-02
04041906505530AESCULAPAesculap AGGYK2023-04-03
04041906505547AESCULAPAesculap AGGYK2023-04-03
04041906505554AESCULAPAesculap AGGYK2023-04-03
04041906505561AESCULAPAesculap AGGYK2023-04-03
04041906505578AESCULAPAesculap AGGYK2023-04-03
04041906505585AESCULAPAesculap AGGYK2023-04-03
04041906505592AESCULAPAesculap AGGYK2023-04-03
04041906505608AESCULAPAesculap AGGYK2023-04-03
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
04041906507404AESCULAPAesculap AGGYK2023-04-03
00763000031268N/AMEDTRONIC PS MEDICAL, INC.GYK2020-07-20
00382830057325Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
00382830057332Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
00382830058193Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
00382830058186Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
10885403070488V. MuellerCAREFUSION 2200, INCGYK2020-04-15
10885403070495V. MuellerCAREFUSION 2200, INCGYK2020-04-15