AccessGUDID - DEVICE: Arthrex® (00888867458031)

GUDID

Device Identifier (DI) Information

Brand Name: Arthrex®
Version or Model: ABS-4063
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ABS-4063
Company Name: ARTHREX, INC.

Primary DI Number: 00888867458031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *Terms of Use

Device Description: JumpStart ClearFit 3.5" x 2.25"

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:	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?
62983	Bioelectric wound dressing	A sterile wound covering containing microcell batteries [e.g., based on silver (Ag)/zinc(Zn)] designed to mimic a physiologic electric field in the presence of a conductive medium (e.g. saline, hydrogel, or wound exudate) to destroy microbial pathogens (antimicrobial) at the dressing surface and help reduce the risk of wound infection. It is intended to cover partial- and full-thickness wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and help create a moist wound-healing environment. It is in the form of a flat sheet/pad, may be designed to absorb wound exudates, but does not have wound-nonadherent properties. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, wound, drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180533	000

Device Exempt from Premarket Submission: No 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: e86fe617-c7ef-4d68-94a6-334a72cc9003
Public Version Date: June 06, 2024
Public Version Number: 1
DI Record Publish Date: May 29, 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: 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)934-4404
Email: complaints@arthrex.com

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