Ambler Surgical

Primary DI
00190660198916
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Irrigating cystotome
Catalog number
131602
Device description
Irrigating cystotome, 25 gauge x 5/8'', vaulted side-cut, packaged individually, sterile, disposable, box of 10
Published
2021-01-04
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNYCystotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660198916PackageGS110In Commercial Distribution
10190660198913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660198916001906601989161906601989160190660198916
1019066019891310190660198913

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(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
Device count
1
DM exempt
true
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04
00190660100469Ambler SurgicalFiberoptic light cable40-5302021-01-04
00190660100476Ambler SurgicalFiberoptic light cable40-5352021-01-04
00190660100483Ambler SurgicalFiberoptic light cable40-8402021-01-04
00190660100490Ambler SurgicalFiberoptic light cable40-8502021-01-04
00190660100506Ambler SurgicalFiberoptic light cable40-8602021-01-04
00190660100513Ambler SurgicalFiberoptic light cable40-5402021-01-04
00190660100520Ambler SurgicalFiberoptic light cable40-6002021-01-04
00190660100537Ambler SurgicalFiberoptic light cable40-6102021-01-04
00190660100544Ambler SurgicalFiberoptic light cable40-1002021-01-04
00190660100551Ambler SurgicalFiberoptic light cable40-6202021-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613046149MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2024-08-15
00840516141183Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2024-08-15
08052276012432Irrigating Cystotome Ang.45° 27Gx16mm AKTIVE SRLHNY2023-12-19
08052276012937Irrigating Cystotome Formed 27G x 16mmAKTIVE SRLHNY2023-12-19
08052276012968Irrigating Cystotome Ang.45° 25G x16 mm AKTIVE SRLHNY2023-12-19
00840516105345Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-10-10
00840516116600Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116617Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116624Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116631Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116648Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116655Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116662Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116679Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116686Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116693Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116709Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116716Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116754Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116761Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116778Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116785Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116792Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116808Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116815Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116822Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116839Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116846Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116853Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116860Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28