AccessGUDID - DEVICE: Adept Medical Drape Support (09421905187411)

GUDID

Device Identifier (DI) Information

Brand Name: Adept Medical Drape Support
Version or Model: B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AM1000B
Company Name: ADEPT MEDICAL LIMITED

Primary DI Number: 09421905187411
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 592534619 *Terms of Use

Device Description: To support the sterile drape over the patient.

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
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?
31225	Bedding support	A device designed as an arched framework which is placed over the body or part of the body (e.g., the legs) of a bed-bound patient/person to be protect this area from the weight of the bedding (i.e., sheet, blankets, duvet) which cover the patient/person.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BWN	Table And Attachments, Operating-Room

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Liquid Chemical

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: b148f7a1-c9ec-44ac-ba4a-5f2a685bfa05
Public Version Date: February 23, 2024
Public Version Number: 1
DI Record Publish Date: February 15, 2024