FDA.reportPublic FDA data

FABCO

Primary DI
50634303550006
Brand
FABCO
Company
FIRST AID BANDAGE CO INC
Model
35500010
Catalog number
35500010
Device description
Neutec® Neurological Pattie • 1/4 X 1/4 Rayon, X-Ray Detectable
Published
2018-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFQGauze/Sponge, Internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50634303550006PackageGS120In Commercial Distribution
30634303550002PrimaryGS10
00634303550001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5063430355000650634303550006
3063430355000230634303550002
00634303550001006343035500016343035500010634303550001

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical spongeA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.25Inch
Length6.4Millimeter
Width0.25Inch
Width6.4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(860) 443-8499customerservice@fabco.net

Regulatory Flags#

DUNS number
001137280
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30634303020192FABCO34116110341161102020-05-13
30634303020277FABCO34320210343202102020-05-14
30634303020284FABCO34320510343205102020-05-14
30634303020291FABCO34322210343222102020-05-14
30634303020307FABCO34340210343402102020-05-14
30634303020321FABCO34340510343405102020-05-14
30634303020338FABCO34340810343408102020-05-14
30634303025258FABCO36171111361711112019-03-15
30634303026200FABCO34821511348215112019-03-15
30634303020536FABCO347051034705102020-05-14
30634303020550FABCO34760510347605102020-05-14
30634303020567FABCO34770510347705102020-05-14
30634303020574FABCO34771010347710102020-05-14
30634303020581FABCO3478051034805102020-05-14
30634303020642FABCO34822010348220102020-05-14
30634303020659FABCO34823010348230102020-05-14
30634303020666FABCO34824010348240102020-05-14
30634303026217FABCO34759111347591112019-03-15
30634303020376FABCO34440210344402102020-05-14
30634303020505FABCO34712010347120102020-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253047509CurityCardinal Health 200, LLCEFQ2026-04-08
50192253067888ASOCardinal Health 200, LLCEFQ2026-01-20
10192253047486TelfaCardinal Health 200, LLCEFQ2025-09-08
B960RED202RED Prep-KitNeuraxis, Inc.EFQ2025-01-09
00630094194110Bioseal Inc.BIOSEALEFQ2023-10-11
10192253047523CurityCardinal Health 200, LLCEFQ2023-10-09
10192253047561CurityCardinal Health 200, LLCEFQ2023-10-09
00665973017228DukalDukal LLCEFQ2022-12-06
00665973017235DukalDukal LLCEFQ2022-12-06
00665973017242DukalDukal LLCEFQ2022-12-06
00683534830017A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830024A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830031A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830048A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830055A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830062A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830079A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830086A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830093A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830109A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830116A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830123A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830130A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830147A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830154A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830161A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830178A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830185A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830277A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830284A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19