AccessGUDID - DEVICE: FirstFUSE 1st MTP Joint Plating System (B471123202550)

GUDID

Device Identifier (DI) Information

Brand Name: FirstFUSE 1st MTP Joint Plating System
Version or Model: 12320255
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GRAMERCY EXTREMITY ORTHOPEDICS LLC

Primary DI Number: B471123202550
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080068420 *Terms of Use

Device Description: MTPJ Plate Large Left, 5 deg Dorsiflexion/5 deg Abduction, EPS

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?
46647	Orthopaedic fixation plate, non-bioabsorbable	A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, fixation, bone

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: 2df32cff-b376-4f9b-9c06-e495b6fa2700
Public Version Date: September 11, 2024
Public Version Number: 3
DI Record Publish Date: October 23, 2020