FDA.reportPublic FDA data

N/A

Primary DI
20705036003967
Brand
N/A
Company
Obtech Medical Sàrl
Model
RGBRS1
Catalog number
RGBRS1
Device description
Gastric Band Dissector
Published
2016-07-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
30705036003964PackageGS112Not in Commercial Distribution
20705036003967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503600396430705036003964
2070503600396720705036003967

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic blunt dissectorA sterile, rigid, manual instrument designed to facilitate blunt dissection between tissue planes during laparoscopic procedures, and may additionally be used during open surgical interventions of the abdomen. It is typically made of high-grade stainless steel and plastic materials, and usually consists of a long, thin shaft with a handle and activation lever proximally, and distally a steerable, flexible blunt tip used to mechanically disrupt tissues. Using the lever, the operator can articulate and lock the tip at an angle. It may also be used to snare and pull a pre-tied suture or interface with other similarly shaped articles (e.g., gastric band tubing). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266customersupport@eesus.jnj.com

Regulatory Flags#

DUNS number
486911852
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20705036003974N/ARGCT180RGCT1802016-07-15
20705036003981N/ARGCT360RGCT3602016-07-15
20705036011788N/ARHUB50RHUB502016-07-15
20705036011795N/ARHUB90RHUB902016-07-15
20705036004018NARLZPT2RLZPT22014-09-17
30705036003964N/ARGBRS1RGBRS12016-07-15
30705036003971N/ARGCT180RGCT1802016-07-15
30705036003988N/ARGCT360RGCT3602016-07-15
30705036004015NARLZPT2RLZPT22014-09-17
20705036004001NARLZB32RLZB322014-09-17
30705036004008NARLZB32RLZB322014-09-17
20705036011665NARLZB22TRLZB22T2014-09-17
20705036011672NARLZB32D1RLZB32D12014-09-17
20705036011689NARLZB32DG1RLZB32DG12014-09-17
20705036011696NARLZB32DGTRLZB32DGT2014-09-17
20705036011702NARLZB32DTRLZB32DT2014-09-17
30705036011785N/ARHUB50RHUB502016-07-15
30705036011792N/ARHUB90RHUB902016-07-15

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
00192896122888DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
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