FDA.report

Ambler Surgical

Primary DI
00190660198992
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Irrigating cystotome
Catalog number
135004
Device description
Irrigating cystotome, 25 gauge x 5/8'', vaulted, short, 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

Related Records

Contact Domains

Product Codes

CodeName
HNYCystotome

Product Code Classifications

CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660198992PackageGS110In Commercial Distribution
10190660198999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660198992001906601989921906601989920190660198992
1019066019899910190660198999

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

Contacts

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 DIBrandModelCatalogPublished
00190660029340Ambler SurgicalThornton triple vertical and 15 degree cutting edg21-328E2021-01-18
00190660000509Ambler SurgicalTendon approximator43-1602021-01-07
00190660002121Ambler SurgicalAir injection cannula1022E2021-01-07
00190660002138Ambler SurgicalAir injection cannula1328E2021-01-07
00190660002145Ambler SurgicalAir injection cannula1023E2021-01-07
00190660002152Ambler SurgicalAir injection cannula1031E2021-01-07
00190660002169Ambler SurgicalAir injection cannula1329E2021-01-07
00190660002176Ambler SurgicalAir injection cannula1026E2021-01-07
00190660002183Ambler SurgicalAir injection cannula1024E2021-01-07
00190660002190Ambler SurgicalAir injection cannula1028E2021-01-07
00190660002206Ambler SurgicalAir injection cannula1029E2021-01-07
00190660002213Ambler SurgicalAir injection cannula1027E2021-01-07
00190660002237Ambler SurgicalAir injection cannula1327E2021-01-07
00190660002244Ambler SurgicalAir injection cannula1030E2021-01-07
00190660002268Ambler SurgicalAir injection cannula1330E2021-01-07
00190660002329Ambler SurgicalAlio LASIK irrigation cannula5193E2021-01-07
00190660002343Ambler SurgicalAnis cortex aspirating cannula1429E2021-01-07
00190660002350Ambler SurgicalAnis cortex aspirating cannula1097E2021-01-07
00190660002824Ambler SurgicalBinkhorst irrigating cannula1332E2021-01-07
00190660002831Ambler SurgicalBinkhorst irrigating cannula1333E2021-01-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00841668145968BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668145982BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668145999BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146002BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146019BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146071BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146095BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146132BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146149BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146170BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146194BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146200BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146231BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146248BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00757770416783Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00757770429943Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00757770433896Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00194613002251MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002275MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002305MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002329MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002336MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002343MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002459MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613052317MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103576MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103620MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103859MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613104245MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613104672MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01