AccessGUDID - DEVICE: Medline (10888277363380)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: MPN10020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPN10020
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10888277363380
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: DRILL BIT, SOLID CORE, AO/QC, 2.0MM

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	No
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?
32859	Orthopaedic bone screw starter/notcher	A hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. This is a reusable device.	Active	false

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store devices in a clean and dry environment. The devices are manufactured from non-degradable materials. When stored under the recommended conditions, the shelf life of this product is not limited.

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2 Millimeter

Device Record Status

Public Device Record Key: 0f4d1a05-1e83-4168-afee-e1d79edfd64c
Public Version Date: November 21, 2024
Public Version Number: 5
DI Record Publish Date: October 14, 2016