AccessGUDID - DEVICE: Novapak (20643169662258)

GUDID

Device Identifier (DI) Information

Brand Name: Novapak
Version or Model: CS3900-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC XOMED, INC.

Primary DI Number: 20643169662258
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 835465063 *Terms of Use

Device Description: NASAL PACKING CS3900-10 NOVAPAK 10PK FRM

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?
44434	ENT space-occupying dressing, animal-derived	A sterile, bioabsorbable material intended to be used to help heal tissue, limit adhesions between mucosal surfaces, and control bleeding after ear/nose/throat (ENT) surgery or trauma. It is typically available as a gel or gelatin sponge; it contains animal-derived components (e.g., collagen), and may additionally contain microbe-derived (biosynthetic) components [e.g., hyaluronic acid (HA)]. In nasal/sinus applications it may be aspirated (removed) from the cavity before absorption.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYA	SPLINT, INTRANASAL SEPTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202623	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
Special Storage Condition, Specify: Store Novapak at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 77faebe3-d0f5-4822-ae79-86102af5c978
Public Version Date: February 16, 2021
Public Version Number: 1
DI Record Publish Date: February 08, 2021

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: 00643169662254 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(800)633-8766
Email: Corporate.UDI@medtronic.com

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