BICEL SOFT TIP I/A curved / 21G terralution BIT21AS

GUDID 07630055244055

Irrigation Aspiration instrument

Medicel AG

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID07630055244055
NIH Device Record Key9bae81ec-4f61-4e40-a6da-bc59e956841a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBICEL SOFT TIP I/A curved / 21G terralution
Version Model NumberBIT21AS
Catalog NumberBIT21AS
Company DUNS487158263
Company NameMedicel AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41717271050
Emailinfo@medicel.com
Phone+41717271050
Emailinfo@medicel.com
Phone+41717271050
Emailinfo@medicel.com
Phone+41717271050
Emailinfo@medicel.com
Phone+41717271050
Emailinfo@medicel.com
Phone+41717271050
Emailinfo@medicel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107630055244055 [Primary]

FDA Product Code

HMXCannula, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-17
Device Publish Date2025-12-09

Devices Manufactured by Medicel AG

07630055212023 - ACCUJECT 2.2-1P INJECTOR SET2025-12-17 The ACCUJECT IOL injector is indicated to fold and insert BVI IOLs approved for use with this injector in the human eye.
07630055244055 - BICEL SOFT TIP I/A curved / 21G terralution2025-12-17Irrigation Aspiration instrument
07630055244055 - BICEL SOFT TIP I/A curved / 21G terralution2025-12-17 Irrigation Aspiration instrument
07630055244031 - BICEL I/A curved / 21G terralution2025-06-05 I/A handpiece
07630055244048 - BICEL I/A curved / 23G terralution2025-06-05 I/A handpiece
07630055241863 - I/A Coaxial Handpiece Set Sophi - 20G/65°2024-12-06 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
07630055241870 - I/A Coaxial Handpiece Set Sophi - 21G/45°2024-12-06 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
07630055241887 - I/A Coaxial Handpiece Set Sophi - 23G/45°2024-12-06 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
07630055241894 - I/A Coaxial Handpiece Set Sophi - 21G/45° Soft-Tip2024-12-06 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.

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