FDA.reportPublic FDA data

Atlanta Healthcare Services OcuDrape®

Primary DI
10852171007954
Brand
Atlanta Healthcare Services OcuDrape®
Company
ATLANTA HEALTHCARE SERVICES, INC.
Model
10852171007954
Catalog number
DRA503
Device description
"Instrument/equipment cover drape, Clear Plastic 22 x 18 in w/ 22"" Tape Strip., single use, Sterile"
Published
2016-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKXDrape, surgical
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852171007954PrimaryGS10
00852171007957Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085217100795410852171007954
00852171007957008521710079578521710079570852171007957

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Inch
Width22Inch

Sterilization Methods#

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

Contacts#

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

Regulatory Flags#

DUNS number
130599421
Device count
40
Premarket exempt
true
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
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
10851736007026Atlanta Healthcare Services OcuDrape®10851736007026ODS5002ANS2016-09-24

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