AccessGUDID - DEVICE: Vive (00810113577586)

GUDID

Device Identifier (DI) Information

Brand Name: Vive
Version or Model: SUP3070BLKM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VIVE HEALTH LLC

Primary DI Number: 00810113577586
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047025993 *Terms of Use

Device Description: Achilles Wedge (Medium)

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):	Yes
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?
58504	Geometric shape exerciser	A physical training and rehabilitation device in various geometric shapes designed to be placed on the floor to support a patient?s body while performing gymnastic movements to regain and/or improve body movement and balance, and/or for strengthening the limbs and the trunk of the body; some types may provide a motion (e.g., rocking). It is typically used by a person with a physical disability/disorder. It is available in various shapes (e.g., cylindrical, square, oblong or curved) and sizes and typically consists of polyurethane foam covered with high-density non-slip, waterproof, washable polyvinyl chloride (PVC) fabrics. The device may be available in a set of different shapes and sizes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITW	Joint, Ankle, External Brace

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: 4857f7e9-23e4-4f26-aded-91a79cc5dd66
Public Version Date: August 26, 2024
Public Version Number: 1
DI Record Publish Date: August 16, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10810113577583	72	00810113577586		In Commercial Distribution	Case

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

No Customer Contact currently defined

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