AccessGUDID - DEVICE: Atlanta Healthcare Services OcuDrape® (10852171007282)

GUDID

Device Identifier (DI) Information

Brand Name: Atlanta Healthcare Services OcuDrape®
Version or Model: 10852171007282
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OPH751NS
Company Name: ATLANTA HEALTHCARE SERVICES, INC.

Primary DI Number: 10852171007282
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 130599421 *Terms of Use

Device Description: Ophthalmic Drape, Incise two fluid pouches and breather bar Clear Poly

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46697	Ophthalmic surgical drape	A protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow, retract lashes or eyelids, completely occlude the eyelid, or completely cover the eye. The device is typically secured directly to the skin with a pressure-sensitive adhesive, and is typically supplied sterile. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMT	Drape, patient, ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K854613	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 44 Inch
Length: 65 Inch

Device Record Status

Public Device Record Key: f19735ea-8bdc-41c8-9a0f-dfa348e8536e
Public Version Date: August 31, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2016