Ambler Surgical

Whitehouse gravity axis marker, 6 1/4'', angled, marks the limbus at 3, 6 and 9 o'clock to avoid the effect of cyclotortion, hind weight position assures excellent visualization and…

Registry build 21.09.26

Whitehouse gravity axis marker, 6 1/4”, angled, marks the limbus at 3, 6 and 9 o’clock to avoid the effect of cyclotortion, hind weight position assures excellent visualization and balance, inner diameter 11mm, outer diameter 13mm

7manufacturers in China registered for this device type
196catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Hubei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HMR
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Ophsurin Co., Ltd. Suqian Jiangsu Contract manufacturer 6
Hubei Lanbin Medical Group Co., Ltd. Xiaogan Hubei Contract manufacturer 33
Asol Co., Ltd. Huaian Jiangsu Manufacturer 22
Huaian Tisurg Medical Instruments Co., Ltd. Huaian Jiangsu Contract manufacturer 22
Belle Healthcare Technology Co., Ltd. Suzhou Jiangsu Manufacturer 20
Sihong Ophsurin Co., Ltd. Suqian Jiangsu Manufacturer 17

Record

Regulatory record for Ambler Surgical
Listed by Ambler Surgical, LLC, United States
FDA product code HMR
Device type Marker, Ocular
Device class Class 1
Regulation 21 CFR 886.4570
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2021-01-04
Record revised 2023-08-03 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Ambler Surgical
Catalogue number Size Status
Bores optic zone marker In distribution
Nordan-Ruiz trapezoidal marker In distribution
Hoffer optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Whitehouse gravity axis marker In distribution
Bores optic zone marker In distribution
Henderson Toric IOL axis marker In distribution
Bores optic zone marker In distribution
DSEK/DSAEK corneal marker In distribution
DSAEK optic zone marker In distribution
Bores optic zone marker In distribution
Bores 2-ray axis marker In distribution
Hoffer optic zone marker In distribution
Lindstrom arcuate incision marker In distribution
John ALK marker In distribution
Hoffer optic zone marker In distribution
Hoffer optic zone marker In distribution
Grandon T-incision marker In distribution
DMEK donor button marker In distribution
Bores low-profile optic zone marker In distribution
Thornton low-profile optical center marker In distribution
Anis radial marker In distribution
Bores low-profile optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Kershner-Nichamin LRI marker In distribution
Bores low-profile optic zone marker In distribution
DSEK corneal marker In distribution
Bores optic zone marker In distribution
Osher-Neumann 4-line corneal marker In distribution
Bores optic zone marker In distribution
Bores optic zone marker In distribution
Bores optic zone marker In distribution
Bores optic zone marker In distribution
Dell LRI astigmatism marker (Gills Nomogram) In distribution
Bores optic zone marker In distribution
Thornton low-profile optical center marker In distribution
Thornton low profile 12-line corneal marker In distribution
Henderson Toric alignment gauge marker In distribution
Hoffer optic zone marker In distribution
Bores optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Bores optic zone marker In distribution
Bores optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Ambler Toric reference marker In distribution
Chayet corneal marker for LASIK In distribution
DSEK/DSAEK corneal marker In distribution
Thornton low-profile optical center marker In distribution
Bores low-profile optic zone marker In distribution
Thornton low profile 6-line corneal marker In distribution
Anis corneal suture placement radial marker In distribution
Ambler Toric Intra-op axis marker In distribution
Hoffer optic zone marker In distribution
Fechtner trabeculectomy marker In distribution
Bores 2-ray axis marker In distribution
Hoffer optic zone marker In distribution
DSAEK optic zone marker In distribution
Thornton low profile 4-line corneal marker In distribution
Anis radial marker In distribution
Bores optic zone marker In distribution
Graether Toric axis marker In distribution
Hoffer optic zone marker In distribution
Grandon T-incision marker In distribution
Thornton low-profile optical center marker In distribution
Thornton low-profile optical center marker In distribution
Thornton low profile 8-line corneal marker In distribution
Thornton low-profile optical center marker In distribution
Bores optic zone marker In distribution
Thornton low-profile optical center marker In distribution
Thornton low-profile optical center marker In distribution
Bores optic zone marker In distribution
Nordan-Ruiz trapezoidal marker In distribution
Thornton low-profile optical center marker In distribution
Machat LASIK marker In distribution
Thornton low-profile optical center marker In distribution
Hoffer optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Anis radial marker In distribution
Bores low-profile optic zone marker In distribution
Nordan-Ruiz trapezoidal marker In distribution
LRI slit lamp gravity marker In distribution
Bores low-profile optic zone marker In distribution
Ellis double-ended astigmatism marker In distribution
Bores low-profile optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Miyata Toric axis marker In distribution
Osher-Neumann 12-line corneal marker In distribution
Bores low-profile optic zone marker In distribution
DSAEK optic zone marker In distribution
Grandon T-incision marker In distribution
Thurmond pachymetry marker In distribution
Toric combo gravity marker In distribution
Hofmann T-incision marker In distribution
Hoffer optic zone marker In distribution
Thornton low-profile optical center marker In distribution
Ambler axis marker In distribution
Bores low-profile optic zone marker In distribution
Kershner-Nichamin LRI marker In distribution
Hoffer optic zone marker In distribution
Anis radial marker In distribution
Hoffer optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Dulaney corneal marker for LASIK In distribution
Bores low-profile optic zone marker In distribution
Bores corneal radial marker In distribution
Ellis astigmatism marker In distribution
Bores low-profile optic zone marker In distribution
Osher-Neumann 16-line corneal marker In distribution
Bores low-profile optic zone marker In distribution
DSAEK optic zone marker In distribution
Thornton low-profile optical center marker In distribution
Bores low-profile optic zone marker In distribution
Hofmann T-incision marker In distribution
Thornton low-profile optical center marker In distribution
Kershner-Nichamin LRI marker In distribution
Bores low-profile optic zone marker In distribution
Bores optic zone marker In distribution
Nordan-Ruiz trapezoidal marker In distribution
Hoffer optic zone marker In distribution
Bores 2-ray axis marker In distribution
Anis radial marker In distribution
Bores low-profile optic zone marker In distribution
Bores low-profile optic zone marker In distribution
Kershner-Nichamin LRI marker In distribution
Hoffer optic zone marker In distribution
O’Connor scleral depressor/marker In distribution
Bores low-profile optic zone marker In distribution
Kellen capsulorhexis marker In distribution
Mendez corneal LASIK marker In distribution
Thornton low-profile optical center marker In distribution
Bores optic zone marker In distribution
Kobayashi DSAEK marker In distribution
Bores low-profile optic zone marker In distribution
Hoffer optic zone marker In distribution
Hofmann T-incision marker In distribution
Bores low-profile optic zone marker In distribution
Thornton low-profile optical center marker In distribution
Hoffer optic zone marker In distribution
Thornton low-profile optical center marker In distribution
Ambler Toric Intra-op axis marker II In distribution
Bores low-profile optic zone marker In distribution
Bores optic zone marker In distribution
DSAEK optic zone marker In distribution
Bores optic zone marker In distribution
Nuijts Toric axis marker In distribution
Gonnin-Amsler marker In distribution
Hoffer optic zone marker In distribution
Anis radial marker In distribution
Hoffer optic zone marker In distribution
Gass scleral marker In distribution
Bores corneal radial marker In distribution
Greene visual axis marker In distribution
Hoffer optic zone marker In distribution
DSAEK optic zone marker In distribution
Thornton low-profile optical center marker In distribution
Hoffer optic zone marker In distribution
Ambler axis marker In distribution
Bores low-profile optic zone marker In distribution
Osher-Neumann 8-line corneal marker In distribution
Bores optic zone marker In distribution
Osher-Neumann 6-line corneal marker In distribution
Hoffer optic zone marker In distribution
Henderson Toric alignment gauge marker In distribution
Bores optic zone marker In distribution
Grandon T-incision marker In distribution
Dell LRI astigmatism marker (Nichamin Nomogram) In distribution
Lu corneal LASIK marker In distribution
Grandon T-incision marker In distribution
Toric/LRI slit lamp marker In distribution
Thornton low-profile optical center marker In distribution
Lindstrom arcuate incision marker In distribution
Henderson LRI marker In distribution
Ambler Toric Intra-op axis marker II In distribution
Bores low-profile optic zone marker In distribution
Bores optic zone marker In distribution
Ambler Toric reference marker In distribution
Bores low-profile optic zone marker In distribution
Kellen capsulorhexis marker In distribution
Bores optic zone marker In distribution
Thornton low-profile optical center marker In distribution
Henderson Toric IOL axis marker In distribution
Bores optic zone marker In distribution
Thornton low-profile optical center marker In distribution
Bores optic zone marker In distribution
DMEK donor button marker In distribution
Ambler Toric reference marker In distribution
Bores optic zone marker In distribution
Bores optic zone marker In distribution
Thornton low-profile optical center marker In distribution
Kershner-Nichamin LRI marker In distribution
Bores low-profile optic zone marker In distribution
Henderson LRI marker In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Walcott Rx Products Walcott Rx Product Inc 188
Mastel Precision Surgical Instruments, Inc. Mastel Surgical Inc. 148
MR Phaco Crestpoint Management Ltd. 125
MSI Precision Specialty Instruments MED Saver, Inc. 122
Millennium Avalign Technologies, Inc. 90
Marker, Ocular Katena Products, Inc. 51
Surgical Direct Surgical Direct, Inc. 40
Rumex Rumex International Co. 37
Duckworth & Kent Duckworth AND Kent Limited 33
Epsilon USA Epsilon EYE Care PVT., Ltd. 28
Bausch + Lomb Bausch & Lomb Incorporated 27
Mrk, Ocular Katena Products, Inc. 26

Showing 12 of 213. All products under Marker, Ocular

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer