AccessGUDID - DEVICE: NA (07613327052237)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0250080134
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0250080134
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327052237
Issuing Agency: GS1
Commercial Distribution End Date: February 15, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: Myoma Drill

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?
36235	Manual surgical rotary handpiece, reusable	A manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCZ	Endoscopic grasping/cutting instrument, non-powered

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter: 10.0 Millimeter

Device Record Status

Public Device Record Key: 294cf119-cc69-4624-ac3d-824bd90d52cd
Public Version Date: September 20, 2021
Public Version Number: 7
DI Record Publish Date: September 23, 2016