AccessGUDID - DEVICE: PolyLock Midfoot (00840124502451)

GUDID

Device Identifier (DI) Information

Brand Name: PolyLock Midfoot
Version or Model: TN-LL-7000-15L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUSION ORTHOPEDICS, LLC

Primary DI Number: 00840124502451
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080307067 *Terms of Use

Device Description: Component 15 Long 20mm

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?
40591	Leg friction/impact protector	A device designed to be worn over the leg to provide a cushion to protect the limb and its skin from friction against surfaces and knocks against objects. It is typically made of fabric or soft padded materials and is held in place with bands or straps around the leg, or has a tubular sock design; it is not dedicated to the ankle/foot. It is typically used by persons who have thinning skin or skin sores on their legs, are bedridden, or prone to lack of control with their legs causing injury. 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 [?]
K211843	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 1433c00e-727b-4ebf-90ba-f4efa2fea26e
Public Version Date: March 15, 2024
Public Version Number: 1
DI Record Publish Date: March 07, 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
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: Yes
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: Yes
Donation Identification Number: Yes CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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