AccessGUDID - DEVICE: I-pak (00814639020694)

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31848	Periodontal probe, reusable	A hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of high-grade stainless steel and has a distal end with a thin, angled or curved blunt tip with scaled markings to indicate measurements (typically millimetres). This is a reusable device.	Obsolete	false
31776	Dental mirror, reusable	A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.	Active	false
35812	Dental surgical probe, reusable	A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.	Active	false

Product Code	Product Code Name
EAX	Mirror, Mouth
EIX	Probe, Periodontic
EKB	Explorer, Operative

Product Code

Product Code Name

EAX

Mirror, Mouth

EIX

Probe, Periodontic

EKB

Explorer, Operative

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

FDA Premarket Submission Number [?]

Supplement Number [?]

Premarket Submission Number Not Available/Not Released

Sterilization Method [?]
No Sterilization Methods Found

Sterilization Method [?]

No Sterilization Methods Found

Storage and Handling
Storage Environment Temperature: less than 40 Degrees Celsius

Storage and Handling

Storage Environment Temperature: less than 40 Degrees Celsius

Size Type Text
No Device Sizes

Size Type Text

No Device Sizes

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30814639020695	50	00814639020694		In Commercial Distribution	box
50814639020699	16	30814639020695		In Commercial Distribution	Carton

Package DI Number

Quantity per Package

Contains DI Package

Package Discontinue Date

Package Status

Package Type

30814639020695

00814639020694

In Commercial Distribution

box

50814639020699

30814639020695

In Commercial Distribution

Carton

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Issuing Agency [?]

Secondary DI Number

No Secondary DIs found

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

DEVICE: I-pak (00814639020694)

Device Identifier (DI) Information

Device Characteristics

GMDN

FDA Product Code

FDA Premarket Submission

Sterilization

Storage and Handling

Clinically Relevant Size

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI

Secondary DI

Unit of Use DI

Direct Marking (DM)

Production Identifier(s) in UDI

Customer Contact