AccessGUDID - DEVICE: PlastCare (D066PGSTRS81831)

GUDID

Device Identifier (DI) Information

Brand Name: PlastCare
Version or Model: PG-STR-S8183
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PG-STR-S8183
Company Name: Proguard Health, Inc

Primary DI Number: D066PGSTRS81831
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 129529337 *Terms of Use

Device Description: X-Ray Sensor Sleeves (8" x 1-5/8")

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
47144	Dental chair, electric	A mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRK	Chair, Examination And Treatment

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 52fca3b5-fe4a-44c5-8ad1-e8d998830e67
Public Version Date: July 12, 2021
Public Version Number: 1
DI Record Publish Date: July 02, 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
D066PGSTRS81832	36	D066PGSTRS81831		In Commercial Distribution

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: D066PGSTRS81830 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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