AccessGUDID - DEVICE: Exact Medical Manufacturing, Inc. (00850003355542)

GUDID

Device Identifier (DI) Information

Brand Name: Exact Medical Manufacturing, Inc.
Version or Model: 9736245
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9736245
Company Name: EXACT MEDICAL MANUFACTURING, INC.

Primary DI Number: 00850003355542
Issuing Agency: GS1
Commercial Distribution End Date: September 25, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 014464314 *Terms of Use

Device Description: Sterile Drapes 9736245 Autoguide 15pk / Sterile Drapes Autoguide 15 pack, Inner case Sterile Drapes 9736245 Autoguide 15pk / Sterile Drapes Autoguide 15 pack,Outer case Control Unit Drape, PE with Elastic Bands 25cm x 100cm - 9.8"x39.4", 15 each Targeting Unit Drape, PE adapters 50cm x 100cm - 19"x39.4", 15 each

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):	No
Over the Counter (OTC):	Yes
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?
47783	Patient surgical drape, single-use	A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KKX	Drape, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3b9bba17-4920-47ad-a3d2-de5f9f756244
Public Version Date: September 26, 2024
Public Version Number: 5
DI Record Publish Date: November 14, 2019