AccessGUDID - DEVICE: NA (00852073002562)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Stylet
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TMI1156
Company Name: C R I

Primary DI Number: 00852073002562
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 130814890 *Terms of Use

Device Description: For use with HSG Catheters

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":	Yes
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?
31670	Catheter stylet	A metal wire or flexible rod, typically with a plastic knob at the proximal end, that is inserted into the lumen of a catheter or cannula to provide internal reinforcement to increase the stiffness enough to facilitate manipulation and introduction into the body for various procedures. It is available in various lengths, diameters, and degrees of rigidity. Some types can include small passive magnets that generate a magnetic field which is detectable by an external catheter stylet magnet detector. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LKF	Cannula, Manipulator/Injector, Uterine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032835	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba35d155-f069-40f4-b83f-59d7c3da93bd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 11, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10852073002569	10	00852073002562		In Commercial Distribution	Box

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

Customer Contact

[?]

Phone: (800) 556-0349
Email: Sales@ThomasMedical.com

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