AccessGUDID - DEVICE: Oxboro™ Pin Cover (00887761003149)

GUDID

Device Identifier (DI) Information

Brand Name: Oxboro™ Pin Cover
Version or Model: 101002PBX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ASPEN SURGICAL PRODUCTS, INC.

Primary DI Number: 00887761003149
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2021
Device Count: 2
Labeler D-U-N-S® Number*: 027680821 *Terms of Use

Device Description: Single use device intended to cover exposed ends of orthopedic pin and k-wires to help protect the exposed wire from snagging on clothing.

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):	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?
17812	Needle guard	A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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: Yes
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: b202e306-d95a-48e1-b7d5-55e012251d01
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: June 11, 2019