AccessGUDID - DEVICE: XTENDOBUTTON (00885556702697)

GUDID

Device Identifier (DI) Information

Brand Name: XTENDOBUTTON
Version or Model: 71935601
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71935601
Company Name: Smith & Nephew, Inc.

Primary DI Number: 00885556702697
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: XTENDOBUTTON Round Small 15 mm DIA

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?
36174	Ligament bone anchor	A non-bioabsorbable device designed to be implanted into bone specifically to attach the ends of a ligament (synthetic or natural source) to the bone, e.g., during reconstructive knee surgery. The device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KGS	RETENTION DEVICE, SUTURE

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
No Device Sizes

Device Record Status

Public Device Record Key: bd958de1-9cbc-4082-a295-5278f33dbdb8
Public Version Date: September 07, 2023
Public Version Number: 3
DI Record Publish Date: May 09, 2018

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)238-7538
Email: GUDID@SMITH-NEPHEW.COM

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