AccessGUDID - DEVICE: Halyard (10680651924985)

GUDID

Device Identifier (DI) Information

Brand Name: Halyard
Version or Model: 92498
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60121
Company Name: Avanos Medical, Inc.

Primary DI Number: 10680651924985
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: HALYARD* Biopsy Forcep

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):	No
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?
32638	Flexible bronchoscopic biopsy forceps, single-use	A flexible manual instrument intended to perform through a compatible bronchoscope to obtain specimens of the bronchi and/or the lungs during endoscopy for histopathological examination. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of scissors-like cups with a cutting edge around their rim which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KGE	FORCEPS, BIOPSY, ELECTRIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K932790	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: 3b9f395b-ecbf-4e39-be09-819cceac16db
Public Version Date: November 16, 2018
Public Version Number: 4
DI Record Publish Date: July 06, 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
30680651924989	5	10680651924985		In Commercial Distribution	CS

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: +1(844)425-9273
Email: xxx@xxx.xxx

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