FDA.reportPublic FDA data

Atlanta Healthcare Services OcuDrape®

Primary DI
10851736007897
Brand
Atlanta Healthcare Services OcuDrape®
Company
ATLANTA HEALTHCARE SERVICES, INC.
Model
10851736007897
Catalog number
ORG103XLNS
Device description
OR Surgical Gown, X/Large, non-reinforced Level III with absorbent towel
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
FYAGOWN, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931562000GUARDIAN SURGEON'S GOWNSAtkins Healthcare Services1994-10-07FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851736007897PrimaryGS10
00851736007890Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085173600789710851736007897
00851736007890008517360078908517360078900851736007890

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
130599421
Device count
40
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
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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