AccessGUDID - DEVICE: SofTIP (10840143909641)

GUDID

Device Identifier (DI) Information

Brand Name: SofTIP
Version or Model: 60-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-0008-02
Company Name: ATRICURE, INC.

Primary DI Number: 10840143909641
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use

Device Description: SofTIP Guide Cannula

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
64565	Pericardioscopic access cannula	A rigid, single-lumen, surgical instrument intended to be percutaneously inserted through the chest and through the pericardial cavity to facilitate the introduction of surgical instruments as part of a minimally-invasive cardiac procedure (e.g., epicardial ablation). It is intended for subxiphoid or transdiaphragmatic access, and once in place is intended to remain in position for the duration of the procedure. It may include a trocar blade intended to assist introduction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090385	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: Store in a cool, dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3b9506c5-cc5f-47a9-a91f-aaed99d0925a
Public Version Date: April 14, 2023
Public Version Number: 1
DI Record Publish Date: April 06, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30840143909645	1	10840143909641		In Commercial Distribution	box
50840143909649	10	30840143909645		In Commercial Distribution	case

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: 866-449-2342
Email: SEhlert@atricure.com

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