FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660192266
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Camellin style LASEK trephine
Catalog number
2095E
Device description
Camellin style LASEK trephine, 4 1/2'', double-ended, 8.0mm trephine with 8.5mm well, flat handle
Published
2021-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRHTrephine, manual, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660192266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660192266001906601922661906601922660190660192266

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgery fluid retention ringA sterile ophthalmic device intended to be placed on the cornea to provide a physical barrier for fluid retention of the eye during ophthalmic surgery. It is a bevelled, hollow cylinder made of high-grade stainless steel, similar in shape to a non-cutting corneal trephine, with a double-walled vacuum ring intended to create an airtight seal. This is a single-use device.

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
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
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00841668146507BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146514BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146521BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146538BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146545BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146552BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146569BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146576BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146590BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146606BarronKATENA PRODUCTS, INC.HRH2026-06-10
05055445956165SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
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