AccessGUDID - DEVICE: INGENIX (00843672100827)

GUDID

Device Identifier (DI) Information

Brand Name: INGENIX
Version or Model: 55258550
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INGENIUMSPINE, LLC

Primary DI Number: 00843672100827
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 082805471 *Terms of Use

Device Description: Iliac screw 8.5x50mm 25 deg

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?
43851	Gravity-convection laboratory oven	A mains electricity (AC-powered) device used for high-temperature laboratory procedures such as baking, drying, desiccating, and sterilizing, through natural heat convection, items placed within it (e.g., glassware, instruments, cultures, or samples). It operates at temperatures from 5? Celsius above ambient temperature up to 250? Celsius. It is available in a variety of designs and chamber sizes, and the chamber is typically lined with corrosion-proof materials (e.g., stainless steel). The device is thermally insulated, has manual or microprocessor-operated controls, heating elements, and time and temperature sensors.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System
KWP	Appliance, Fixation, Spinal Interlaminal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173126	000

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: 4549b99e-fee9-4e09-8504-23fc4f235b73
Public Version Date: June 14, 2024
Public Version Number: 3
DI Record Publish Date: June 15, 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

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES