AccessGUDID - DEVICE: FILE (00888118085726)

GUDID

Device Identifier (DI) Information

Brand Name: FILE
Version or Model: 54-386-10-07
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KLS-Martin L.P.

Primary DI Number: 00888118085726
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 826499238 *Terms of Use

Device Description: FINGERNAIL

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:	No
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?
38812	Nail scissors, reusable	A hand-held device designed specifically for cutting the nails of a patient. It is comprised of two pivoted blades with finger and thumb ring-handles, which cut the nails with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed); the blades may be curved to follow the natural curvature of human nails. It is not a pair of nail clippers. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEO	FILE, SURGICAL, GENERAL & PLASTIC SURGERY

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 CM

Device Record Status

Public Device Record Key: ade45574-3395-4025-81e1-ec32bca6d4a0
Public Version Date: August 26, 2024
Public Version Number: 5
DI Record Publish Date: September 26, 2018

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

Customer Contact

[?]

Phone: +1(904)641-7746
Email: KLS-UDI-Info@klsmartin.com

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