{"publicDeviceRecordKey":"1763534d-e2b6-4067-99ec-aeefbd156fde","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2020-08-31T00:00:00.000Z","devicePublishDate":"2016-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10852171007015","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00852171007018","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Atlanta Healthcare Services  OcuDrape®","versionModelNumber":"10852171007015","catalogNumber":"AHS1172NS","dunsNumber":"130599421","companyName":"ATLANTA HEALTHCARE SERVICES, INC.","deviceCount":40,"deviceDescription":"Ophthalmic Drape Clear Poly Head with SMS Body, Gutter Pouch, Breather Bar and Wipe","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(404)812-9886","phoneExtension":null,"email":"service@ocudrape.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K854613","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46697","gmdnPTName":"Ophthalmic surgical drape","gmdnPTDefinition":"A protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow, retract lashes or eyelids, completely occlude the eyelid, or completely cover the eye. The device is typically secured directly to the skin with a pressure-sensitive adhesive, and is typically supplied sterile. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HMT","productCodeName":"Drape, patient, ophthalmic"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Width","size":{"unit":"Inch","value":"65"},"sizeText":null,"sizeString":"Width: 65 Inch"},{"sizeType":"Length","size":{"unit":"Inch","value":"85"},"sizeText":null,"sizeString":"Length: 85 Inch"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Ethylene Oxide"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}