AccessGUDID - DEVICE: DR -HOS (06970742221695)

GUDID

Device Identifier (DI) Information

Brand Name: DR -HOS
Version or Model: NN-SH-Blue
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Guangzhou Xinbo Electronic Co., Ltd.

Primary DI Number: 06970742221695
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530683813 *Terms of Use

Device Description: One shoulder support. Made of cloth, the device is worn on the body

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
41464	Elbow/wrist/hand orthosis	An externally applied orthopaedic appliance or apparatus designed to encompass the elbow joint, the wrist joint, and the whole or part of the hand to support, correct, or improve function of the elbow, wrist, and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MNE	Orthosis, Moldable, Supportive, Skin Protective

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: f2f7cbfd-19dd-4b90-88a1-ff9d340ce53c
Public Version Date: September 09, 2021
Public Version Number: 1
DI Record Publish Date: September 01, 2021

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

Customer Contact

[?]

No Customer Contact currently defined

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