AccessGUDID - DEVICE: Gel Therapy Glove, Pair (00614464007866)

GUDID

Device Identifier (DI) Information

Brand Name: Gel Therapy Glove, Pair
Version or Model: 786
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Silipos Holding LLC

Primary DI Number: 00614464007866
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056112948 *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:	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?
60522	Skin treatment/dressing-supportive glove/mitten, reusable	A garment intended to be worn on the hand(s) of a patient affected by a skin condition/disorder (e.g., eczema, wound, fragile skin) to protect the skin typically after treatment with a medication (e.g., ointment, cream), prevent scratching, and/or to support a dressing over a wound/injury. It is typically made of non-allergenic natural materials or a composite (e.g., viscose/nylon/elastane), and intended for use in the home and healthcare facility. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, Skin Pressure

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: db5cd263-ce3d-42b3-9ec1-bb2373ce4abf
Public Version Date: August 15, 2022
Public Version Number: 1
DI Record Publish Date: August 05, 2022

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES