AccessGUDID - DEVICE: 6.0 X 90MM OUTER SLEEVE (00816950029820)

GUDID

Device Identifier (DI) Information

Brand Name: 6.0 X 90MM OUTER SLEEVE
Version or Model: 303-6003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 303-6003
Company Name: Osteocentric Technologies, Inc.

Primary DI Number: 00816950029820
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 089645059 *Terms of Use

Device Description: 6.0 X 90MM OUTER SLEEVE

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
63105	Orthopaedic instrument extractor	A hand-held manual surgical instrument designed to extract another orthopaedic instrument (e.g., instrument sleeve/guide) from a patient’s body during an orthopaedic surgical procedure. It is a robust instrument intended to clamp to the device intended to be extracted during the procedure; it is not intended for device introduction/insertion and is not intended for extraction of an implant. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, Surgical, Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160603	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
Outer Diameter: 6.0 Millimeter
Length: 90 Millimeter

Device Record Status

Public Device Record Key: 47e1c4d2-755a-447b-b617-5d684395797f
Public Version Date: May 19, 2025
Public Version Number: 4
DI Record Publish Date: February 16, 2022