AccessGUDID - DEVICE: NA (04058749000023)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MOA-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MOA-2
Company Name: Fehling Instruments GmbH & Co. KG

Primary DI Number: 04058749000023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028238 *Terms of Use

Device Description: Biopsy forceps, single use sterile, 1,6 x 800 mm

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?
46679	Endomyocardial biopsy forceps, single-use	A sterile grasping instrument designed to obtain tissue samples from the inner walls of the heart (endomyocardium) typically for histopathological examination. It is typically a flexible metal coil or plastic tube with a pair of scissors-like cups with cutting edges around their rims at the distal end which are operated by a handle attached at the proximal end. It is usually introduced percutaneously through the jugular vein or femoral artery (during catheterization). Acquired tissue samples are typically used for assessment of early rejection of a transplanted heart, cardiomyopathy and myocarditis diagnosis, or detection of antracycline cardiotoxicity. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWZ	Device, Biopsy, Endomyocardial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170726	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 409c18b6-2c5e-44db-b8fe-7f9bdc8399f2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 23, 2017

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: 800 334-5464
Email: info@fehlingsurgical.com

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