AccessGUDID - DEVICE: IPS (00888118142405)

GUDID

Device Identifier (DI) Information

Brand Name: IPS
Version or Model: 60-500-31-09-LP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KLS-Martin L.P.

Primary DI Number: 00888118142405
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 826499238 *Terms of Use

Device Description: No description.

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?
67349	Fixed dental occlusal splint, custom-made	A rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, typically in the perioperative period after trauma or orthognathic surgery (surgical orthodontics). It is fixed to the teeth with ligature wires by a clinician and is intended to remain in place short-term (<=30 days) until sufficient bone healing has taken place. The device is manufactured to meet the needs of an individual patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZJ	DRIVER, WIRE, AND BONE DRILL, MANUAL
JEY	PLATE, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 28a1acbe-20f0-40fa-8608-2c3bae9bb9b7
Public Version Date: November 07, 2024
Public Version Number: 3
DI Record Publish Date: May 22, 2023

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

Customer Contact

[?]

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES