FDA.reportPublic FDA data

Atlanta Healthcare Services OcuDrape®

Primary DI
10852171007831
Brand
Atlanta Healthcare Services OcuDrape®
Company
ATLANTA HEALTHCARE SERVICES, INC.
Model
10852171007831
Catalog number
S338NS
Device description
PVA Corneal Light Shield 8mm Diameter x 1mm, Non-sterile
Published
2016-11-14
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
HOZSponge, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOZSponge, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942642000SURGI-WIPESurgin Surgical Instrumentation, Inc.1994-07-15HOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852171007831PrimaryGS10
00852171007834Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085217100783110852171007831
00852171007834008521710078348521710078340852171007834

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic spongeA device made of absorbent material, e.g., gauze, cotton or cellulose, intended to be used to absorb excess fluid produced by the eye during microsurgical procedures and ophthalmic surgery such as cataract surgery and laser assisted in situ keratomileusis (LASIK) procedures. Some types can be used as an eyelid and lash guard and are typically shaped for use in conjunction with an eye speculum. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1Millimeter
Outer Diameter8Millimeter

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Radiation Sterilization""]"

Contacts#

Phone, Email table
PhoneEmail
+1(404)812-9886service@ocudrape.com

Regulatory Flags#

DUNS number
130599421
Device count
400
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10852171007091Atlanta Healthcare Services OcuDrape®10852171007091DRA73722016-09-24
10851736007750Atlanta Healthcare Services OcuDrape®10851736007750OPH500NS2016-11-14
10851736007767Atlanta Healthcare Services OcuDrape®10851736007767DRA5002016-11-14
10851736007798Atlanta Healthcare Services OcuDrape®10851736007798AHS4475EPNS2016-11-14
10851736007804Atlanta Healthcare Services OcuDrape®10851736007804BTC4475EPSMSNS2016-11-14
10851736007811Atlanta Healthcare Services OcuDrape®10851736007811BTC4490EPSMSNS2016-11-14
10852171007176Atlanta Healthcare Services OcuDrape®10852171007176OPH501NS2016-11-14
10852171007183Atlanta Healthcare Services OcuDrape®10852171007183DRA73522016-11-14
10852171007190Atlanta Healthcare Services OcuDrape®10852171007190OPH504NS2016-11-14
10852171007633Atlanta Healthcare Services OcuDrape®10852171007633OPH507NS2016-11-14
10852171007947Atlanta Healthcare Services OcuDrape®10852171007947OPH503NS2016-10-24
10852171007954Atlanta Healthcare Services OcuDrape®10852171007954DRA5032016-10-24
10851736007996Atlanta Healthcare Services Ocudrape10851736007996OES5702CS2023-07-13
00851736007999Atlanta Healthcare Services Ocudrape10851736007996OES5702CS2023-07-13
10851736007873Atlanta Healthcare Services OcuDrape®10851736007873ORG102LGNS2016-11-14
10851736007880Atlanta Healthcare Services OcuDrape®10851736007880SORG102LG2016-11-14
10851736007897Atlanta Healthcare Services OcuDrape®10851736007897ORG103XLNS2016-11-14
10851736007903Atlanta Healthcare Services OcuDrape®10851736007903SORG103XL2016-11-14
10851736007002Atlanta Healthcare Services OcuDrape®10851736007002AHS850ANS2016-09-24
10851736007019Atlanta Healthcare Services OcuDrape®10851736007019DRA850A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840516145747Anodyne SurgicalPsi/Eye-Ko, Inc.HOZ2026-04-17
00840516145761Anodyne SurgicalPsi/Eye-Ko, Inc.HOZ2026-04-17
10385640090008WalcottSummit Medical, Inc.HOZ2026-02-03
10385640090015WalcottSummit Medical, Inc.HOZ2026-02-03
30385640090019WalcottSummit Medical, Inc.HOZ2026-02-03
20385640090005WalcottSummit Medical, Inc.HOZ2026-02-03
20385640090012WalcottSummit Medical, Inc.HOZ2026-02-03
40385640090016WalcottSummit Medical, Inc.HOZ2026-02-03
04260306710522Sugi sterile, sample, ophthalmologyQuestAlpha GmbH & Co. KGHOZ2025-08-15
00194613056841MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056872MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056896MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
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00194613118785MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118792MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118808MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118983MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118990MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119003MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119010MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119027MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056889MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-03-21
00194613018276MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
00194613060749MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
10194613018273MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
10194613060746MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
04260306710478SugiQuestAlpha GmbH & Co. KGHOZ2024-07-31