AccessGUDID - DEVICE: Aquaplast PS™ (10841962118511)

GUDID

Device Identifier (DI) Information

Brand Name: Aquaplast PS™
Version or Model: PS-1728
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PS-1728
Company Name: Qfix

Primary DI Number: 10841962118511
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 808875397 *Terms of Use

Device Description: Ivory, 3/32", 3 x 3" Nasal Splint Blanks

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
35411	External nasal splint	A rigid or semi-rigid device intended to be applied externally to the nose for the immobilization of nasal bones and cartilage, typically after a fracture or surgery. It functions as a truss-like support on the outside of the nose. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EPP	SPLINT, NASAL

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 3 Inch
Depth: 0.094 Inch
Width: 3 Inch

Device Record Status

Public Device Record Key: b01fdbf3-a7d2-4dfd-b0bc-1b568906982d
Public Version Date: December 11, 2023
Public Version Number: 2
DI Record Publish Date: December 20, 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: 10841962118528 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(610)268-0585
Email: Compliance@qfix.com

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