AccessGUDID - DEVICE: NA (03596010495914)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 7210149
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7210149
Company Name: Smith & Nephew, Inc.

Primary DI Number: 03596010495914
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: BONE TUNNEL PLUGS CANN 7-12MM LTX

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):	Yes
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?
61510	Bone tunnel plug, cannulated	A sterile device intended to be inserted into a bone tunnel during an arthroscopic procedure to reduce the loss of the irrigation fluid used to maintain visualization, while allowing the passage of instruments (e.g., probes, guide pins, shavers and graspers) through its lumen to access the joint. It is a short, rigid, cannulated tube which tapers distally with a penetrable seal on the proximal end. It is inserted manually into the bone tunnel, or may be supplied with dedicated instruments for insertion (e.g., obturator). The device is available in a variety of diameters, and is typically made of plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	ARTHROSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K925437	000

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
Special Storage Condition, Specify: 0

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6cd29ba1-7d7a-4d01-bb8b-770b6fa9367c
Public Version Date: July 07, 2025
Public Version Number: 4
DI Record Publish Date: August 30, 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
23596010495918	6	03596010495914		In Commercial Distribution	BX

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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