AccessGUDID - DEVICE: EPS Plating System (B471712400010)

GUDID

Device Identifier (DI) Information

Brand Name: EPS Plating System
Version or Model: 71240001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GRAMERCY EXTREMITY ORTHOPEDICS LLC

Primary DI Number: B471712400010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080068420 *Terms of Use

Device Description: Plate Bender (2) Pack 1.5mm

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?
61211	Manual orthopaedic bender, single-use	A sterile, manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXW	BENDER

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
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f3e78104-a79d-4192-a921-778aa523d1e2
Public Version Date: November 02, 2020
Public Version Number: 1
DI Record Publish Date: October 23, 2020