FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660001759
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Castroviejo caliper
Catalog number
14-111
Device description
Castroviejo caliper, 3 1/2'', straight tips, measures from 0-20mm in 0.5mm increments, adjustable thumb-screw tension
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
HOECaliper, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOECaliper, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660001759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660001759001906600017591906600017590190660001759

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic calliperA hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye. Some types, known as a blepharometer, can be used to measure the thickness of the eyelid and the force of the lid closure.

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
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
00198506089053ELMED INCORPORATEDELMED INCORPORATEDHOE2026-03-03
00852194002090HAI CaliperHightech American Industrial Labs IncHOE2025-12-16
09348811124524INKAThe Trustee for KAISER FAMILY TRUSTHOE2025-11-28
00810207782575Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00810207782582Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00194613007409MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007423MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007430MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007454MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007508MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613051952MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613112783MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
04058935011055Castroviejo CaliperBausch & Lomb GmbHHOE2025-07-10
04058935011062Castroviejo Marking CaliperBausch & Lomb GmbHHOE2025-07-10
G412PH94030MR PHACOCrestpoint Management LimitedHOE2025-06-09
G412PH94071T0MR PHACOCrestpoint Management LimitedHOE2025-06-09
G412PH9408T0MR PHACOCrestpoint Management LimitedHOE2025-06-09
G2231113910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOE2025-06-04
G412PH20330MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH61270MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62500MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62510MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62520MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62540MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62550MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62560MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6433L0MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6433R0MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6434L0MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6434R0MR PHACOCrestpoint Management LimitedHOE2025-05-27