FDA.reportPublic FDA data

Atlanta Healthcare Services OcuDrape®

Primary DI
10851736007705
Brand
Atlanta Healthcare Services OcuDrape®
Company
ATLANTA HEALTHCARE SERVICES, INC.
Model
10851736007705
Catalog number
AHS550NS
Device description
"Fluid Pouch 500cc 12"" wide x 7"" deep, 12"" x 1-1/2"" adhesive tape, forming bar"
Published
2016-09-24
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
HMTDrape, patient, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMTDrape, Patient, OphthalmicGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K854613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854613000SURGICAL DRAPES, OPHTHALMINCharles Atkins & Co.1986-02-13HMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851736007705PrimaryGS10
00851736007708Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085173600770510851736007705
00851736007708008517360077088517360077080851736007708

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tissue/fluid collection bag, non-sterileA non-sterile flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch
Width12Inch

Sterilization Methods#

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

Contacts#

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

Regulatory Flags#

DUNS number
130599421
Device count
500
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

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