AccessGUDID - DEVICE: WOLF Plate, 96mm, 7 Hole (00816101011940)

GUDID

Device Identifier (DI) Information

Brand Name: WOLF Plate, 96mm, 7 Hole
Version or Model: NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TO-LBP-096
Company Name: TOBY ORTHOPAEDICS

Primary DI Number: 00816101011940
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024163331 *Terms of Use

Device Description: The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.

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):	No
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 [?]
K131834	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a8b2d796-eb96-4efb-8284-c3f09674ab8d
Public Version Date: November 06, 2024
Public Version Number: 3
DI Record Publish Date: August 15, 2020