AccessGUDID - DEVICE: NA (00844868002284)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: DS2315
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BIOMET 3I, LLC

Primary DI Number: 00844868002284
Issuing Agency: GS1
Commercial Distribution End Date: March 24, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 186127825 *Terms of Use

Device Description: DRILL STOP, 2.3MM-3.25MM X 15MM

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?
47863	Surgical instrument/implant depth limiter, reusable	A device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control insertion depth, typically to prevent insertion below the surgical field of interest thereby avoiding damage to tissue behind or below target structures. It is typically made of high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter 3.25 mm
Length: 15 Millimeter
Device Size Text, specify: Diameter 2.3 mm

Device Record Status

Public Device Record Key: c6b209b6-f597-4833-8ccc-16d059add092
Public Version Date: November 07, 2024
Public Version Number: 7
DI Record Publish Date: November 12, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)342-5454
Email: 3iPBG-CS@biomet.com

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