AccessGUDID - DEVICE: ActivaPin™ (E302BAP32609)

GUDID

Device Identifier (DI) Information

Brand Name: ActivaPin™
Version or Model: B-AP-3260
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B-AP-3260
Company Name: Bioretec Oy

Primary DI Number: E302BAP32609
Issuing Agency: HIBCC
Commercial Distribution End Date: November 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 368715301 *Terms of Use

Device Description: ActivaPin™ 3.2 mm x 60 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
45037	Orthopaedic bone pin, bioabsorbable	A device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTY	Pin, Fixation, Smooth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080879	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Millimeter
Width: 3.2 Millimeter

Device Record Status

Public Device Record Key: 2d75f125-3249-4fb3-ae18-2a95cb0bb33a
Public Version Date: January 23, 2026
Public Version Number: 5
DI Record Publish Date: August 25, 2015