FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660036065
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
4126E
Catalog number
4126E
Device description
Silicone eye sphere, 19.0mm diameter, packaged individually, non-sterile, disposable, box of 1
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HPZIMPLANT, EYE SPHERE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPZImplant, Eye SphereOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112176000SILICONE SPHERESOculo Plastik, Inc.2011-09-15HPZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660036065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660036065001906600360651906600360650190660036065

GMDN Terms#

Term, Definition table
TermDefinition
Orbital sphere implantAn implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.

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
Lot or batch
true
Manufacturing date on label
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
13700773728111SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2026-02-17
13700773724397EZYPOR® Ø 18 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773724403EZYPOR® Ø 20 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773724410EZYPOR® Ø 22 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728081EZYPOR® Ø 16 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728852EZYPOR® Ø 12 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728890EZYPOR® Ø 14 mm FCI S A S FCI 20 22HPZ2024-06-21
B09114150010mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114151012mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114152014mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114153016mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114154018mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114155020mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114156022mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
03760087123715SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2021-05-30
13760087123712SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2021-05-30
03760087122435Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122442Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122459Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122466Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122473Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122480Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122510Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122527Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122916Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122923Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122930Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122954Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122961Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122985Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06