AccessGUDID - DEVICE: Adept Medical Drape Support (09421902825941)

GUDID

Device Identifier (DI) Information

Brand Name: Adept Medical Drape Support
Version or Model: AM1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AM1000
Company Name: ADEPT MEDICAL LIMITED

Primary DI Number: 09421902825941
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 592534619 *Terms of Use

Device Description: Table Accessory to support drape over 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: 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: 04e5c093-b450-43a2-ad14-ae25373001a1
Public Version Date: August 27, 2018
Public Version Number: 1
DI Record Publish Date: July 25, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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