AccessGUDID - DEVICE: Custom Healthcare Systems Inc. (00811870032189)

GUDID

Device Identifier (DI) Information

Brand Name: Custom Healthcare Systems Inc.
Version or Model: D40-11262
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Manus Medical, LLC

Primary DI Number: 00811870032189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800604196 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
37942	Palate prosthesis	An artificial substitute for the hard palate used to reproduce the function of the palate typically in cases of a palatal cleft or fistula, or for palatal augmentation. It will help to improve the patient's speech and eating ability by occluding the defective opening, and in some cases by improving the positioning of their tongue and improving swallowing. Teeth are usually mounted on the device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRO	General Surgery Tray

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 6e34b21f-5eb1-4752-843f-023ec0d8ccd3
Public Version Date: June 08, 2023
Public Version Number: 2
DI Record Publish Date: July 27, 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
20811870032183	50	00811870032189		In Commercial Distribution	N/A

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: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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