AccessGUDID - DEVICE: GAP ENDO-EXO MEDULLARY SYSTEM (07540194001146)

GUDID

Device Identifier (DI) Information

Brand Name: GAP ENDO-EXO MEDULLARY SYSTEM
Version or Model: GAP-LG070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GAP-LG070
Company Name: Pega Medical Inc

Primary DI Number: 07540194001146
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 257315713 *Terms of Use

Device Description: Lag Screw Ø5.5mm X 70mm

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?
44854	Arthrodesis nail, fixed-length	A rod of fixed-length (i.e., not intended for distraction) intended to be implanted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] for the purpose of joint fusion or arthrodesis; it is not dedicated to femur or tibia implantation. The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: keep at room temperature

Clinically Relevant Size

[?]

Size Type Text
Length: 70 Millimeter
Outer Diameter: 5.5 Millimeter

Device Record Status

Public Device Record Key: 00dfd450-eb71-430e-93f4-f5aa976e8941
Public Version Date: September 18, 2023
Public Version Number: 4
DI Record Publish Date: October 20, 2016