AccessGUDID - DEVICE: N/A (07613327582024)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 5220030290
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5220-030-290
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327582024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: 9mm Acorn TPS M

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?
46269	Cranial bur, single-use	A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBE	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 10 and 85 KiloPascal
Handling Environment Temperature: between 10 and 27 Degrees Celsius
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter: 9.0 Millimeter

Device Record Status

Public Device Record Key: d3d3863c-f7bf-48de-9383-0159ef579d54
Public Version Date: July 06, 2022
Public Version Number: 1
DI Record Publish Date: June 28, 2022

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +0018002533210
Email: Inst.Stryker.cs@Stryker.com

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