AccessGUDID - DEVICE: TACK-3-PT (00841336100015)

GUDID

Device Identifier (DI) Information

Brand Name: TACK-3-PT
Version or Model: Rev3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SALVIN DENTAL SPECIALTIES, LLC

Primary DI Number: 00841336100015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113344790 *Terms of Use

Device Description: SALVIN POWER TIP TITANIUM BONE TACK-3MM (PKG OF 5)

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?
46640	Craniofacial bone tack, non-bioabsorbable	A small, cylindrical shaft typically with a flat, rounded head at one end and tapered to a point at the other, that is driven into craniofacial bone (includes maxilla and/or mandible) to provide stabilization for fracture repair and reconstructive procedures (e.g., dental regeneration membrane fixation); it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., titanium alloy). The device may be used when rigid fixation with bone plates and screws is not required.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DZL	Screw, Fixation, Intraosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100182	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: dd84bbb8-04e3-4ce6-bd24-61b716ce0b1f
Public Version Date: June 21, 2024
Public Version Number: 6
DI Record Publish Date: October 30, 2015

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

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