Frigitronics

Primary DI
00888937004335
Brand
Frigitronics
Company
Coopersurgical, Inc.
Model
121
Device description
2.08mm Pediatric Retinal Curved Probe. Tip: 1.0mm length x 2.08mm diameter. Shaft: 27mm length x 2.84mmmm diameter
Published
2016-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HQAUnit, Cryotherapy, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQAUnit, Cryotherapy, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937004335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937004335008889370043358889370043350888937004335

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cryosurgical system applicator, retinalA hand-held device that is a component of an electronic ophthalmic cryosurgical system designed for the application of cold, produced by a cryogen from a cylinder connected via the system control unit, to retinal tissue for various therapeutic applications (e.g., to treat retinal tears and detachments) during ophthalmic surgery. It is typically formed as a handpiece with an insulated grip and attached tubing with connector for attachment to the control unit, and is available with a variety of tip configurations (e.g., curved, midreach, right angle, extended reach). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
801895244
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
1084009621142623ga Multi-Flex™ Extendable Laser Probe, Quantel ConnectorKATALYST SURGICAL LLCHQA2020-03-25
1081748902661523ga MultiFlex™ Extendable Laser Probe, Iridex ConnectorKATALYST SURGICAL LLCHQA2017-12-17
00888937019896TrichiasisCoopersurgical, Inc.HQA2017-09-27
00888937009422FrigitronicsCoopersurgical, Inc.HQA2016-08-02
00888937004052FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004069FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004076FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004083Frigitronics Coopersurgical, Inc.HQA2016-07-20
00888937004090FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004106FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004113FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004120FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004137FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004144FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004151FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004168FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004175FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004182FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004199FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004205FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004212FrigitronincsCoopersurgical, Inc.HQA2016-07-20
00888937004229FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004236FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004243FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004250FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004267FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004274FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004281FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004298FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004304FrigitronicsCoopersurgical, Inc.HQA2016-07-20