AccessGUDID - DEVICE: Avalign (00190776048846)

GUDID

Device Identifier (DI) Information

Brand Name: Avalign
Version or Model: VM106-3136
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Avalign Technologies, Inc.

Primary DI Number: 00190776048846
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 792528510 *Terms of Use

Device Description: Tivnen Tonsil Forceps, 3x3 teeth, angled, one open ring TW 9mm, OL 203mm (7")

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:	No
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?
36199	ENT soft-tissue cutting forceps	A hand-held manual surgical instrument with a biting action intended to be used to punch/cut/excise soft-tissue during an ear/nose/throat (ENT) procedure [e.g., adenoidectomy, tonsillectomy, sinus surgery, septoplasty, and/or biopsy]. It is a metallic instrument with a distal mechanism designed to bite tissue when the handles are squeezed together; some types may be used endoscopically (e.g., through a laryngopharyngoscope), and may include an integrated fluid suction channel for improved surgical field viewing. It is not intended for cutting bone (i.e., not a rongeur). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAE	FORCEPS, ENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: f154ac45-e9de-4be7-8372-2962c1961c5f
Public Version Date: November 21, 2023
Public Version Number: 1
DI Record Publish Date: November 13, 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
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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)289-1096
Email: product.questions@avalign.com

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