Atlanta Healthcare Services OcuDrape® DRA1272

GUDID 10852171007114

Ophthlamic/Oculoplastic adherent window drape Incise 7.25x3.25 in., non-woven

ATLANTA HEALTHCARE SERVICES, INC.

Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape Ophthalmic surgical drape
Primary Device ID10852171007114
NIH Device Record Keya66a08ba-2df7-413e-8d58-5845306b4f27
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtlanta Healthcare Services OcuDrape®
Version Model Number10852171007114
Catalog NumberDRA1272
Company DUNS130599421
Company NameATLANTA HEALTHCARE SERVICES, INC.
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com
Phone+1(404)812-9886
Emailservice@ocudrape.com

Device Dimensions

Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch
Length43 Inch
Width41 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100852171007117 [Unit of Use]
GS110852171007114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HMTDrape, patient, ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

[10852171007114]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-08-31
Device Publish Date2016-09-24

On-Brand Devices [Atlanta Healthcare Services OcuDrape®]

10851736007903OR Surgical Gown Sterile, X/Large, non-reinforced Level III with absorbent towel
10851736007897OR Surgical Gown, X/Large, non-reinforced Level III with absorbent towel
10851736007880OR Surgical Gown, Sterile, Large, non-reinforced Level III with absorbent towel
10851736007873OR Surgical Gown, Large, non-reinforced Level III with absorbent towel
10852171007008Ophthalmic Drape, Clear Poly Head with SMS Body, Gutter Pouch, Breather Bar and Wipe
10852171007954Instrument/equipment cover drape, Clear Plastic 22 x 18 in w/ 22" Tape Strip., single use, Steri
10852171007947Instrument/equipment cover drape, Clear Plastic 22 x 18 in w/ 22" Tape Strip., single use, Non-s
10852171007824PVA Eye Drain Wick 8 Inch, Non-sterile
10852171007817PVA Instrument Wipe with adhesive backing STERILE
10852171007800PVA Instrument Wipe with adhesive backing , Non-sterile
10852171007794PVA Ophthalmic Wipe 3IN1 Wipe, Drain Wick, Corneal Light Shield 80mm x 76mm x 2mm STERILE
10852171007787PVA Ophthalmic Wipe 3IN1 Wipe, Drain Wick, Corneal Light Shield 80mm x 76mm x 2mm
10852171007770PVA Instrument Wipe Kit, 2IN1 Wipe & Eye Drain Wick, Corneal Light Shield, STERILE
10852171007763PVA Instrument Wipe Kit, 2IN1 Wipe & Eye Drain Wick,Corneal Light Shield Non-sterile
10852171007756PVA Instrument Wipe with Eye Drain Wick 2IN1, Round Corners 2mm, STERILE
10852171007749PVA Instrument Wipe with Eye Drain Wick 2IN1, Round Corners 2mm, Non-sterile
10852171007732PVA Instrument Wipe, Square 76 mm x 76 mm x 2mm STERILE
10852171007725PVA Instrument Wipe, Square 76 mm x 76 mm x 2mm, Non-sterile
10852171007718PVA Instrument Wipe, Round Corners 80 mm x 76 mm x 2mm STERILE
10852171007701PVA Instrument Wipe, Round Corners 80 mm x 76 mm x 2mm Non-sterile
10852171007633Suture Bag-Utility Cover, Clear Plastic 8x15" with Tape Strip & Gusset
10852171007558Ophthalmic Drape, Oval Aperture with Fluid Pouch
10852171007541Ophthalmic Drape, Oval Aperture with Fluid Pouch
10852171007534Ophthalmic Drape, Full Incise with Fluid Pouch
10852171007527Ophthalmic Drape, Full Incise with Fluid Pouch
10852171007503Ophthalmic Drape, Oval Aperture 2.5 In. wide x 1.5 In., Embossed Plastic 16 In. x 16 In.
10852171007497Ophthalmic Drape, Oval Aperture 2.5 In. wide x 1.5 In., Embossed Plastic 16 In. x 16 In.
10852171007480Ophthalmic Drape, Full Incise, Embossed Plastic 16 In. x 16 In.
10852171007473Ophthalmic Drape, Full Incise, Embossed Plastic 16 In. x 16 In.
10852171007466Ophthalmic Drape, Round Aperture, Embossed Plastic 16 In. x 16 In.
10852171007459Ophthalmic Drape, Round Aperture, Embossed Plastic 16 In. x 16 In.
10852171007435Ophthalmic Bilateral Fenestrated Drape with Adhesive Tape , Blue SMS non-woven
10852171007428Ophthalmic Drape, Full Incise, No Pouch 48 x 51 Embossed Plastic
10852171007411Ophthalmic Drape, Aperture, Embossed Plastic, 48" X 51"
10852171007404Ophthalmic Drape Incise with Single Fluid Pouch, Embossed Plastic 48 x 51 In.
10852171007398Ophthalmic Drape, Aperture, Single Fluid Pouch w/PVA Eye Drain Embossed Plastic 40x48"
10852171007381Ophthalmic Drape Incise with single fluid pouch
10852171007374Ophthalmic Drape, Round Incise 3 In., No pouches, Blue Non-woven
10852171007367Ophthalmic Drape, Incise, No pouches, Blue Non-woven
10852171007350Ophthalmic Drape, Oval Aperture 3" with Adhesive, No Pouch, Blue Non-woven
10852171007329Ophthalmic Drape, Incise, Breather Bar, NO POUCH, Blue SMS Non-woven
10852171007312Ophthalmic Drape, Aperture, Breather Bar, NO POUCH, Blue SMS Non-woven
10852171007305Ophthalmic Drape, Aperture, Clear Poly Drape with 3-side gutter pouch, breather bar
10852171007299Ophthalmic Drape, Incise, Clear Poly with 3-side gutter pouch, breather bar
10852171007282Ophthalmic Drape, Incise two fluid pouches and breather bar Clear Poly
10852171007275Ophthalmic Drape, Aperture, two fluid pouches, breather bar Clear Poly
10852171007268Ophthalmic Drape, Incise with fluid pouches & breather bar Clear Poly
10852171007251Ophthalmic Drape, Aperture with fluid pouches & breather bar Clear Poly
10852171007190Remote Control Cover, Clear Plastic w/ tape and flap
10852171007183Cover, Mayo Cover Clear Plastic, Phaco Tray Cover with Cuff 24" Wide
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.