AccessGUDID - DEVICE: TSI (00851797006474)

GUDID

Device Identifier (DI) Information

Brand Name: TSI
Version or Model: DS-0022
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TEDAN SURGICAL INNOVATIONS, L.L.C.

Primary DI Number: 00851797006474
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791619393 *Terms of Use

Device Description: QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX

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?
66937	Spinal intraoperative positioning pin, single-use	A nonimplantable thin rod intended to be temporarily introduced, with a dedicated inserter (not included), into vertebral bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, distractor/retractor) during spinal surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

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: 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
Length: 12 Millimeter

Device Record Status

Public Device Record Key: 2591c63e-106b-4435-961e-3749df2fd686
Public Version Date: July 01, 2024
Public Version Number: 4
DI Record Publish Date: May 22, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10851797006471	5	00851797006474		In Commercial Distribution	Inner 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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