AccessGUDID - DEVICE: PF Nail 130°, Long, Right, Ø9x420mm, PPS (09120116975618)

GUDID

Device Identifier (DI) Information

Brand Name: PF Nail 130°, Long, Right, Ø9x420mm, PPS
Version or Model: 1F0R09-420-130A-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1F0R09-420-130A-S
Company Name: I.T.S. GmbH

Primary DI Number: 09120116975618
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 303456917 *Terms of Use

Device Description: PF Nail 130°, Long, Right, Ø9x420mm, PPS

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
33187	Femur intramedullary nail	A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: keep out of sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3997e788-16dc-4b92-b06b-4d0b52f1befe
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: August 05, 2024