FDA.reportPublic FDA data

Streamline Surgical System

Primary DI
00892064002102
Brand
Streamline Surgical System
Company
NEW WORLD MEDICAL, INCORPORATED
Model
10-0066
Catalog number
10-0066
Device description
Streamline
Published
2025-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMXCannula, ophthalmic
MRHPump, infusion, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1
MRHPump, Infusion, OphthalmicGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211680000Streamline Surgical SystemNew World Medical, Inc.2021-10-08MRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00892064002102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00892064002102008920640021028920640021020892064002102

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(909)466-4304orders@newworldmedical.com

Regulatory Flags#

DUNS number
622768711
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00892064002072Streamline Surgical System10-006610-00662023-11-01
00892064002089Ahmed ClearPath STST25010-06092024-12-18
00892064002096Ahmed ClearPath STST35010-06102024-12-18
00892064002355Ahmed™ ClearPath350CP3502019-01-23
00892064002188Ahmed™ Glaucoma ValveTETE2020-08-12
00892064002348Ahmed™ ClearPath250CP2502019-01-23
00892064002294Kahook Dual BladeKDBKDB2016-11-22
00892064002003Kahook Dual Blade GlideKDB Glide10-00652020-10-13
00892064002362VIA360 Surgical SystemVIA36010-06152025-02-18
00892064002010Streamline® Surgical System10-006610-00662021-11-01
00892064002126Ahmed™ Glaucoma ValveFP8FP82017-09-08
00892064002119Ahmed™ Glaucoma ValveFP7FP72016-11-16
00892064002331Ahmed Tube InserterTITI2018-10-11
00892064002133Ahmed™ Glaucoma ValveS2S22015-03-24
00892064002140Ahmed™ Glaucoma ValveS3S32015-03-24
00892064002270Ahmed™ Glaucoma ValveM4M42015-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600088329110Maskin MG Probe 1mmMGD INNOVATIONS, LLCHMX2026-05-07
G22312643590Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G223140461200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G346EEC0330Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMX2026-03-18
G22312624110Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2025-09-10
G412CA14030MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14040MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14050MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14060MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14070MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14080MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14090MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14100MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14110MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14120MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14130MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14140MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14150MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14160MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14170MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14180MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14190MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14200MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14210MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14220MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14230MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14240MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14250MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14260MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14270MR PHACOCrestpoint Management LimitedHMX2025-05-27