AccessGUDID - DEVICE: GoldenDent (00850011211786)

GUDID

Device Identifier (DI) Information

Brand Name: GoldenDent
Version or Model: GO-SIK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GO-SIK
Company Name: GoldenDent

Primary DI Number: 00850011211786
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078273228 *Terms of Use

Device Description: Separators Intro Kit (GO-SS1, GO-SS2, GO-SS3, GO- SS4, GO-SS5, GO SS6, GO SS7)

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
31814	Dental dressing forceps, reusable	A hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device.	Active	false
16480	Dental elevator, tooth/root	A hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMJ	ELEVATOR, SURGICAL, DENTAL
DZN	INSTRUMENTS, DENTAL HAND

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: 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: dc037628-ad90-46e5-9234-d9f6cff023b2
Public Version Date: March 05, 2021
Public Version Number: 1
DI Record Publish Date: February 25, 2021

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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