FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660036706
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Fine-Thornton swivel fixation ring
Catalog number
3312TR
Device description
Fine-Thornton swivel fixation ring, 5 1/4'', C-shaped, 16.0mm diameter swivel head, 11.0mm cut-out, round handle, titanium
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
HNHRING, OPHTHALMIC (FLIERINGA)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNHRing, Ophthalmic (Flieringa)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660036706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660036706001906600367061906600367060190660036706

GMDN Terms#

Term, Definition table
TermDefinition
Scleral marker, reusableA manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel). Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. This is a reusable 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
Primary DIBrandCompanyProduct codePublished
04251047906688Hofmann-Thornton Fixation RingA1 Medical GmbHHNH2026-06-09
04251047935398Gerten Easy Liquid Bubble DMEKA1 Medical GmbHHNH2026-06-09
08435194334969AJL Vacuum Centering GuideAJL OPHTHALMIC SAHNH2026-03-12
04058935013547 Ring Fixation Fine Thornton 16Bausch & Lomb GmbHHNH2025-10-26
04058935013554 Ring Fixation Fine-Thornton 13Bausch & Lomb GmbHHNH2025-10-26
00757770418855Bausch + LombBausch & Lomb IncorporatedHNH2025-08-07
00757770481835Bausch + LombBausch & Lomb IncorporatedHNH2025-08-07
00190776406738MillenniumAvalign Technologies, Inc.HNH2025-07-23
G412PH95400MR PHACOCrestpoint Management LimitedHNH2025-06-09
G412PH21150MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH21900MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190080MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190090MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190100MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190110MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190120MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190130MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190140MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190150MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190160MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190170MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190180MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190190MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190200MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190210MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190220MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190230MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190240MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH95000MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH9500T0MR PHACOCrestpoint Management LimitedHNH2025-06-07