AccessGUDID - DEVICE: ClearView MV Atrial Depressor (00818354013955)

GUDID

Device Identifier (DI) Information

Brand Name: ClearView MV Atrial Depressor
Version or Model: 001-400-005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ATRICURE, INC.

Primary DI Number: 00818354013955
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use

Device Description: ClearView MV Atrial Depressor

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":	Yes
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?
35313	Cardiac retractor	A hand-held manual surgical instrument designed to separate or draw aside the edges of an incision in the heart, various anatomical structures of the heart (e.g., an atrium or aortic valve), or the entire organ. It consists of a handle proximally and a wire frame-like blade, with no sharp edges, that can have various shapes and angles at the distal tip. It is made of high-grade stainless steel and may have a synthetic material for the handle (e.g., Tufnol). This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053021	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: 5f986dab-fbd7-4f11-a066-5647a2cbf72b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2016

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: 866-349-2342
Email: xxx@xxx.xxx

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