FDA.reportPublic FDA data

FABCO

Primary DI
00634303020740
Brand
FABCO
Company
FIRST AID BANDAGE CO INC
Model
34911510
Catalog number
34911510
Published
2020-05-14
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
GDIDissector, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30634303020741PrimaryGS10
00634303020740Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063430302074130634303020741
00634303020740006343030207406343030207400634303020740

GMDN Terms#

Term, Definition table
TermDefinition
Dissection spongeA sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.5Inch
Outer Diameter0.375Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8604438499customerservice@fabco.net

Regulatory Flags#

DUNS number
001137280
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
07898789390039GRAIVIER MID-FACE DISSECTOR LEFTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390046GRAIVIER MID-FACE DISSECTOR RIGHTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390060FRONTO MARTINS 2 ENDOFOREHEAD DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390015TREPSAT FACELIFT DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-23
00196449034512Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
06971503600209comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503600216comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602951comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602968comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602975comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602982comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503602999comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603941comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603958comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603965comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
06971503603972comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
00841732129337GENERIC Surgical InstrumentsCTL Medical CorporationGDI2025-06-04
00840183523046BR Surgical, LLCBR Surgical, LLCGDI2024-03-06
00850036790013AveliRevelle Aesthetics, Inc.GDI2024-02-26
10840199523402DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533302DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533319 DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533326DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533357DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533364DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533371DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533449DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533456DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533463DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533470DissectorKOROS U.S.A., INC.GDI2024-02-06