FDA.report

UNITY

Primary DI
10380650003963
Brand
UNITY
Company
Alcon Laboratories, Inc.
Model
00380650003966
Catalog number
8065000396
Device description
27GA Short Unity Infusion Cannula with Tubing Management Device
Published
2025-04-08
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

Product Codes

CodeName
NGYCannula, Trocar, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
NGYCannula, Trocar, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10380650003963PackageGS112In Commercial Distribution
00380650003966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065000396310380650003963
00380650003966003806500039663806500039660380650003966

GMDN Terms

TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

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00380658544232Clareon TruPlusRECWT3RECWT3.0752026-03-23
00380658544249Clareon TruPlusRECWT3RECWT3.0802026-03-23
00380658544256Clareon TruPlusRECWT3RECWT3.0852026-03-23
00380658544263Clareon TruPlusRECWT3RECWT3.0902026-03-23
00380658544270Clareon TruPlusRECWT3RECWT3.0952026-03-23
00380658544287Clareon TruPlusRECWT3RECWT3.1002026-03-23
00380658544294Clareon TruPlusRECWT3RECWT3.1052026-03-23
00380658544300Clareon TruPlusRECWT3RECWT3.1102026-03-23
00380658544317Clareon TruPlusRECWT3RECWT3.1152026-03-23
00380658544324Clareon TruPlusRECWT3RECWT3.1202026-03-23
00380658544331Clareon TruPlusRECWT3RECWT3.1252026-03-23
00380658544348Clareon TruPlusRECWT3RECWT3.1302026-03-23
00380658544355Clareon TruPlusRECWT3RECWT3.1352026-03-23
00380658544362Clareon TruPlusRECWT3RECWT3.1402026-03-23
00380658544379Clareon TruPlusRECWT3RECWT3.1452026-03-23
00380658544386Clareon TruPlusRECWT3RECWT3.1502026-03-23
00380658544393Clareon TruPlusRECWT3RECWT3.1552026-03-23
00380658544409Clareon TruPlusRECWT3RECWT3.1602026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10380650003499ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003505ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003550ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003567ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003581ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003598ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003956UNITYAlcon Laboratories, Inc.NGY2025-04-08
20380650004677ALCONAlcon Laboratories, Inc.NGY2025-04-08
20380650004684UNITYAlcon Laboratories, Inc.NGY2024-11-19
20380650004707AlconAlcon Laboratories, Inc.NGY2024-11-19
10380650003529ALCONAlcon Laboratories, Inc.NGY2024-07-02
10380650003536ALCONAlcon Laboratories, Inc.NGY2024-07-02
1871787203493223G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
1871787203494925G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
1871787203495627G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
1871787203485723G Two Step Cannula set with High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203486423G Single TrocarD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203487125G Single TrocarD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203488827G Single TrocarD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203489523G Cannula set with High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203490125G Cannula set with High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203491827G Cannula set with High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
10803878053058Aurotrocar AUROLABNGY2023-06-27
08052276015334Trocar 29G with removable valveAKTIVE SRLNGY2023-06-12
08052276015327Trocar 27G with removable valve AKTIVE SRLNGY2023-06-12
08056477557938Trocar set 27g with removable valve AKTIVE SRLNGY2023-06-12
08052276015358Trocar 20g with removable valveAKTIVE SRLNGY2023-06-12
08056477558515Trocar 23G with removable valveAKTIVE SRLNGY2023-06-12
08056477557143Trocar 25G with removable valveAKTIVE SRLNGY2023-06-12
08056477558546Trocar set 20G with removable valve AKTIVE SRLNGY2023-06-12