AccessGUDID - DEVICE: ProCure (10840330703885)

GUDID

Device Identifier (DI) Information

Brand Name: ProCure
Version or Model: PCSPNS1W
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PCSPNS1W
Company Name: Twin Med, LLC

Primary DI Number: 10840330703885
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107071289 *Terms of Use

Device Description: ProCure No Sting Barrier Film 1ml Wand - 25ea/bx 4bx/cs

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":	Yes
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?
58978	Synthetic-polymer liquid barrier dressing	A liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEC	Bandage, Liquid, Skin Protectant

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from fire sources of ignition. Store in dry, ventilated environment. Store at room temperature.

Clinically Relevant Size

[?]

Size Type Text
Width: 14.8 Millimeter
Height: 129 Millimeter

Device Record Status

Public Device Record Key: d59294ec-6fb3-4489-92a7-6e8ffd05fcad
Public Version Date: February 29, 2024
Public Version Number: 1
DI Record Publish Date: February 21, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30840330703889	25	10840330703885		In Commercial Distribution	Box
50840330703883	4	30840330703889		In Commercial Distribution	Case

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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 612-819-1635
Email: sanderson@twinmed.com

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