AccessGUDID - DEVICE: Microlyte Matrix (00850019162240)

GUDID

Device Identifier (DI) Information

Brand Name: Microlyte Matrix
Version or Model: ML0404
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMBED BIOSCIENCES, INC.

Primary DI Number: 00850019162240
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962084500 *Terms of Use

Device Description: Microlyte Matrix, 4 cm x 4 cm, Individually Packaged

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:	Yes
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?
48073	Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial	A wound covering, typically made of a hydrocolloid, intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag)]. It is intended to protect and facilitate healing of minor cuts, scrapes, abrasions, lacerations, blisters, and scalds by absorbing wound exudates while creating a moist wound-healing environment and reducing microbial colonization within the dressing. The device is typically in the form of a flat sheet/film and is intended for use in the home or a clinical setting. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153756	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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 16 Square centimeter

Device Record Status

Public Device Record Key: 3256322c-0568-40a7-921b-c9e15ecfbe76
Public Version Date: July 26, 2024
Public Version Number: 1
DI Record Publish Date: July 18, 2024

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: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 888-472-9898
Email: cs@imbedbio.com

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