AccessGUDID - DEVICE: Posicast® Thermoplastic (10841439101701)

GUDID

Device Identifier (DI) Information

Brand Name: Posicast® Thermoplastic
Version or Model: 930030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 930030
Company Name: MEDTEC, INC.

Primary DI Number: 10841439101701
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103977526 *Terms of Use

Device Description: LPR3 Microperfo mask with profiles

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:	No
Prescription Use (Rx):	Yes
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?
40896	Patient positioning thermoplastic mould material	A thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heating in hot water and while softened, are moulded around the patient's anatomy. When cooled, it hardens to form a custom-made mould or cast of that part of the body. After the moulding process is complete, it is typically attached to a board, frame, or another patient positioning system (PPS) or immobilization device. After application, this device cannot be reused (i.e., remoulded).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, nuclear magnetic resonance imaging
IYE	Accelerator, linear, medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060737	000
K093738	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Keep away from sunlight
Storage Environment Temperature: less than 100 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 752e4e52-b09d-4597-b7e0-6df36c489735
Public Version Date: August 03, 2020
Public Version Number: 7
DI Record Publish Date: September 25, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00841439101704	10	10841439101701		In Commercial Distribution

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: Yes
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

[?]

Phone: +1(712)737-8688
Email: radiotherapy.complaints@civcort.com

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