FDA.reportPublic FDA data

N.A.

Primary DI
04049368172260
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
42311
Catalog number
42311
Device description
N.A.
Published
2021-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NGYCannula, trocar, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGYCannula, Trocar, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049368172260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049368172260040493681722604049368172260

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cannulation set, single-useA collection of non-powered devices intended to be used to create a channel through the sclera for posterior segment ophthalmic surgery. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316267202
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049368016328N.A.38240382402021-02-23
04049368145219N.A.38210382102021-02-23
04049368145226N.A.38215382152021-02-23
04049368172505N.A.40006400062021-02-23
04049368172512N.A.40008400082021-02-23
04049368014201N.A.33960339602021-02-23
04049368015420N.A.38634386342021-02-23
04049368114154N.A.31306313062021-02-23
04049368127895N.A.32935329352021-02-23
04049368127925N.A.32936329362021-02-23
04049368127932N.A.32937329372021-02-23
04049368127994N.A.32944329442021-02-23
04049368133810N.A.33831338312021-02-23
04049368140818N.A.36282362822021-02-23
04049368141181N.A.36312363122021-02-23
04049368141631N.A.36364363642021-02-23
04049368141648N.A.36366363662021-02-23
04049368141655N.A.36368363682021-02-23
04049368169680N.A.32947329472021-02-23
04049368171423N.A.38606386062021-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380650003492ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003508ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003553ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003560ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003584ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003591ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003959UNITYAlcon Laboratories, Inc.NGY2025-04-08
00380650003966UNITYAlcon Laboratories, Inc.NGY2025-04-08
00380650004673ALCONAlcon Laboratories, Inc.NGY2025-04-08
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
10380650003963UNITYAlcon Laboratories, Inc.NGY2025-04-08
20380650004677ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650004680UNITYAlcon Laboratories, Inc.NGY2024-11-19
00380650004703AlconAlcon Laboratories, Inc.NGY2024-11-19
20380650004684UNITYAlcon Laboratories, Inc.NGY2024-11-19
20380650004707AlconAlcon Laboratories, Inc.NGY2024-11-19
00380650003522ALCONAlcon Laboratories, Inc.NGY2024-07-02
00380650003539ALCONAlcon Laboratories, Inc.NGY2024-07-02
10380650003529ALCONAlcon Laboratories, Inc.NGY2024-07-02
10380650003536ALCONAlcon Laboratories, Inc.NGY2024-07-02
0871787203493523G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
0871787203494225G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
0871787203495927G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
1871787203493223G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21