AccessGUDID - DEVICE: SUMMIT MEDICAL (00810061911234)

GUDID

Device Identifier (DI) Information

Brand Name: SUMMIT MEDICAL
Version or Model: 3000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3000
Company Name: KRISHNA IMPORTS INC

Primary DI Number: 00810061911234
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 081853285 *Terms of Use

Device Description: ACCUFLO, STERILE, SMALL

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):	No
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?
36237	Lacrimal punctum plug	A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZU	Plug, Punctum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140352	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.75 Millimeter

Device Record Status

Public Device Record Key: 2b79c557-1e44-4f8a-91ca-ec5acbf336c3
Public Version Date: January 22, 2024
Public Version Number: 1
DI Record Publish Date: January 12, 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: 00810061911982 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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: 859-259-4925
Email: INFO@STEPHENSINST.COM

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