AccessGUDID - DEVICE: GYRUS ACMI, INC (00821925019232)

GUDID

Device Identifier (DI) Information

Brand Name: GYRUS ACMI, INC
Version or Model: 143007
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gyrus ACMI, LLC

Primary DI Number: 00821925019232
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007198742 *Terms of Use

Device Description: VOCOM SHIM 0 MM OFFSET DENSE HYDROXYLAPATITE

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?
60859	Larynx prosthesis	A sterile implantable device intended to replace the larynx to provide normal functionality (i.e., breathing, swallowing, and vocalization) following laryngectomy, usually as a treatment for cancer. It consists of a permanently implanted metal (e.g., titanium) tube, with a temporary silicone tube extension initially implanted to facilitate alignment and tissue integration while the airway is maintained with a tracheostoma. Initially a cap occludes the proximal end of the prosthesis, which is later replaced by a valve-like device; the prosthesis is designed to function without a tracheostoma.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K974311	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: c018a880-fa1e-4f94-8afe-88078c1bd819
Public Version Date: September 02, 2024
Public Version Number: 7
DI Record Publish Date: October 24, 2015

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: 1(800)262-3540
Email: xxx@xxx.xxx

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