AccessGUDID - DEVICE: Avalign (00190776134952)

GUDID

Device Identifier (DI) Information

Brand Name: Avalign
Version or Model: VM81-2486
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Avalign Technologies, Inc.

Primary DI Number: 00190776134952
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 792528510 *Terms of Use

Device Description: Decker Rongeur, straight, CW 2mm, CL 5.5mm, SL 150mm(5 7/8"), OL 200mm(7 7/8")

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?
13418	Neurosurgical rongeur	A hand-held manual surgical instrument designed with a cutting/biting action used for the removal of bone, e.g., pieces of the skull, during a neurosurgical intervention. It is a strongly constructed instrument that has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. It is available in various sizes and is made of high-grade stainless steel and designed to withstand the forces which are applied. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HAE	Rongeur, Manual

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: d481518b-239b-48b5-8575-8d770b496ce4
Public Version Date: July 06, 2023
Public Version Number: 2
DI Record Publish Date: October 23, 2018

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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