AccessGUDID - DEVICE: FABCO (30634303550064)

GUDID

Device Identifier (DI) Information

Brand Name: FABCO
Version or Model: 35501510
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 35501510
Company Name: FIRST AID BANDAGE CO INC

Primary DI Number: 30634303550064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 001137280 *Terms of Use

Device Description: Neutec® Neurological Pattie • 1/2 X 2 Rayon, X-Ray Detectable

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":	No
For Single-Use:	Yes
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?
13702	Neurosurgical sponge	A sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFQ	Gauze/Sponge, Internal

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 50.8 Millimeter
Length: 12.7 Millimeter
Width: 2 Inch
Length: 0.5 Inch

Device Record Status

Public Device Record Key: 4df5c298-d3a4-4358-bb69-22174b37d6d6
Public Version Date: January 31, 2019
Public Version Number: 1
DI Record Publish Date: December 31, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50634303550051	20	30634303550064		In Commercial Distribution	Dispenser Box

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00634303550063 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: (860) 443-8499
Email: customerservice@fabco.net

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES