AccessGUDID - DEVICE: Pliers (D701PLM2)

GUDID

Device Identifier (DI) Information

Brand Name: Pliers
Version or Model: PL-M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PULPDENT CORPORATION

Primary DI Number: D701PLM2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001006089 *Terms of Use

Device Description: College Pliers, Meriam, 6” (15 cm)

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:	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?
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

FDA Product Code

[?]

Product Code	Product Code Name
EJY	Pliers, Operative

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: cc6f1a93-f854-4d4e-aebf-62f0e03c4ef8
Public Version Date: October 01, 2021
Public Version Number: 1
DI Record Publish Date: September 23, 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: No
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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