FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660106249
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Southern eye bank of New Orleans cutting block
Catalog number
33-0002
Device description
Southern eye bank of New Orleans cutting block, 41 x 28 x 19mm, teflon block with two wells
Published
2021-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNJPunch, corneo-scleral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNJPunch, Corneo-ScleralOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660106249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660106249001906601062491906601062490190660106249

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cutting/shaping boardA non-sterile, stiff, plastic device designed to be used as a surface for trimming/contouring objects or tissues [e.g., porous polyethylene (PE) orthopaedic implants, corneal transplants] in an operating room (OR) or other clean room during a surgical procedure. It may be flat or contoured and/or have measurement graduations as a visual approximation aid. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660083373Ambler SurgicalAmbler ingrown tissue hook37-1292021-01-07
00190660086343Ambler SurgicalR-Style nerve hook37-8252021-01-07
00190660086350Ambler SurgicalR-Style nerve hook37-8272021-01-07
00190660086367Ambler SurgicalR-Style nerve hook37-8262021-01-07
00190660086374Ambler SurgicalR-Style nerve hook37-8282021-01-07
00190660086381Ambler SurgicalYasargil micro hook37-8722021-01-07
00190660086398Ambler SurgicalYasargil micro hook37-8702021-01-07
00190660121549Ambler SurgicalR-Style needle57-4262021-01-07
00190660121556Ambler SurgicalR-Style needle57-4282021-01-07
00190660141578Ambler SurgicalSalinger reduction instrument73-1252021-01-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770419807Bausch + LombBausch & Lomb IncorporatedHNJ2026-04-29
00757770500437Bausch + LombBausch & Lomb IncorporatedHNJ2025-08-15
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00194613086510MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086527MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086879MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087005MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087012MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
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00194613087555MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
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00194613111908MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111915MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613123604MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01