← Back to catalogue

TorFlex Transseptal Guiding Sheath

FDA UDI

Class II (US FDA UDI)

by Baylis Médicale Cie Inc

Identity

Trade Name
TorFlex Transseptal Guiding Sheath FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire FDA UDI
Model / Reference
TF8-32-63-90 FDA UDI
Description
TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire FDA UDI

Identifiers

Primary DI / UDI-DI
00685447003793 FDA UDI
FDA Product Code
DQY FDA UDI
DRE FDA UDI
DYB FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
870.1310 FDA UDI
870.1340 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

TorFlex Transseptal Guiding Sheath by Baylis Médicale Cie Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Baylis Médicale Cie Inc

Sources (1)

  • FDA UDI 15f03439-176a-438f-86dd-86b2f04b9974 36 fields · synced May 31, 2026