AccessGUDID - DEVICE: IMPlate (00841506102221)

GUDID

Device Identifier (DI) Information

Brand Name: IMPlate
Version or Model: IMPLATE Awl, Wrist Arthrodesis Nails
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IMP-WAN-AWL
Company Name: SKELETAL DYNAMICS L.L.C.

Primary DI Number: 00841506102221
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 869056148 *Terms of Use

Device Description: No description.

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:	No
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?
66274	Bone awl, single-use	A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a single-use device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092720	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 6832be7d-2e5f-4f5f-b62f-461b3d089eab
Public Version Date: December 25, 2023
Public Version Number: 4
DI Record Publish Date: October 30, 2015