AccessGUDID - DEVICE: GCB Medical Supply Novaplus (00850061859020)

GUDID

Device Identifier (DI) Information

Brand Name: GCB Medical Supply Novaplus
Version or Model: VGCB0210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VGCB0210
Company Name: GCB MEDICAL LLC

Primary DI Number: 00850061859020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086699722 *Terms of Use

Device Description: GCB MEDICAL NOVAPLUS BLUE BOUFFANT, LATEX FREE ELASTIC

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?
32297	Surgical cap, single-use	A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYF	Cap, Surgical

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: 32ff03f8-ba56-4840-b994-079264bd8364
Public Version Date: July 31, 2025
Public Version Number: 1
DI Record Publish Date: July 23, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00850061859129	10	00850061859020		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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (833) 422-6331
Email: info@gcbmedicalsupply.com

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