AccessGUDID - DEVICE: LimbLogic (00194711300150)

GUDID

Device Identifier (DI) Information

Brand Name: LimbLogic
Version or Model: LLV-01050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LLV-01050
Company Name: Willowwood Global LLC

Primary DI Number: 00194711300150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004280723 *Terms of Use

Device Description: LimbLogic 2 Side Mount Adhesive Seal, 2/pack

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:	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?
64716	External lower-limb prosthesis suspensory component, powered	A powered device intended to be integrated in the socket of an external lower limb prosthesis to provide prosthesis suspension by reducing the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It is designed as a vacuum pump (e.g., electric, mechanical) to provide increased vacuum inside the socket.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISP	Valve, Prosthesis

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: 3704b7c9-c551-4386-a3ed-a6a0787a70b8
Public Version Date: March 31, 2025
Public Version Number: 1
DI Record Publish Date: March 21, 2025

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

Customer Contact

[?]

Phone: 740-869-3377
Email: xx@xx.xx

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