FDA.reportPublic FDA data

Raptor

Primary DI
00724995183660
Brand
Raptor
Company
US Endoscopy
Model
00711178
Catalog number
00711178
Device description
The disposable Raptor grasping device-mini is be used to grasp tissue and or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
Published
2020-03-19
Public version status
Update
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
OCZEndoscopic grasping/cutting instrument, non-powered
PTSEndoscopic grasping/cutting instrument, non-powered, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCZEndoscopic Grasping/Cutting Instrument, Non-PoweredGastroenterology, Urology2
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120084000ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.2012-05-30OCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995183667PackageGS15In Commercial Distribution
00816765012567PreviousGS10
00724995183660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518366710724995183667
00816765012567008167650125678167650125670816765012567
00724995183660007249951836607249951836600724995183660

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic tissue manipulation forceps, single-useA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10724995184015Endo-Boot00711621007116212020-04-01
10724995184022Endo-Boot00711622007116222020-04-01
00724995190637ProArmor00711623007116232020-07-16
00724995190644ProArmor00711624007116242020-07-16
00724995180355NA3905133905132020-04-02
00724995180362CO2MPACT7103007103002020-04-02
00724995180386NA7103047103042020-04-02
00724995180409NA7104247104242020-04-02
00724995180416NA7104257104252020-04-02
00724995180423NA7104267104262020-04-02
00724995180430NA7106027106022020-04-02
00724995180447NA7106037106032020-04-02
00724995180454NA7106047106042020-04-02
00724995180522Torrent00711579007115792020-04-01
00724995180768UltramatrixUSBOLUSBOL2020-04-02
00724995180775UltramatrixUSBORUSBOR2020-04-02
00724995180782iSnare00711084007110842020-03-19
00724995180843Articulator00711804007118042020-04-01
00724995182472Short Throw00711018007110182020-03-19
00724995182489Short Throw00711019007110192020-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664944677NAHangzhou AGS MedTech Co., Ltd.PTS2026-08-21
00858836007126DiLumen Interventional GrasperLUMENDI LLCPTS2026-08-07
00850083048006SimpleSnipENVISION ENDOSCOPY, INC.OCZ2026-07-17
00850083048068SimpleSnipENVISION ENDOSCOPY, INC.OCZ2026-07-17
00810116023943Dornier MedTech DORNIER MEDTECH AMERICA, INC.PTS2026-04-17
00816207021744EndoTExtractorENDO-THERAPEUTICS, INC.PTS2026-03-03
00850025860628Rotatable Grasping ForcepMicro-tech UsaPTS2025-03-04
00816207021386EndoTBasketENDO-THERAPEUTICS, INC.OCZ2025-02-26
04260206311706stentfix OTSC System SetOvesco Endoscopy Usa, Inc.OCZ2024-09-13
00860001219821ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219845ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
04055207041130HYSAFERichard Wolf GmbHOCZ2023-01-03
00860009064720g-Prox EZ Endoscopic GrasperUsgi Medical, Inc.OCZ2022-12-20
00860009064737g-Prox EZ Endoscopic GrasperUsgi Medical, Inc.OCZ2022-12-20
00816207020952EndoTGrasperENDO-THERAPEUTICS, INC.OCZ2022-09-21
00724995217044RaptorUS EndoscopyPTS2022-03-18
04547410454482FUJIFILMFUJIFILM CORPORATIONPTS2021-05-26
00724995180614CentraUS EndoscopyPTS2021-03-31
00724995180621CentraUS EndoscopyPTS2021-03-31
00724995180638CentraUS EndoscopyPTS2021-03-31
00724995180645CentraUS EndoscopyPTS2021-03-31
04260206311287stentfix OTSC System SetOvesco Endoscopy AGOCZ2020-09-23
00858836007102DiLumen Interventional GrasperLUMENDI LLCPTS2020-08-25
00724995184063Histoguide wire guided forcepsUS EndoscopyPTS2020-04-01
00724995183653RaptorUS EndoscopyOCZ2020-03-19
00724995183653RaptorUS EndoscopyPTS2020-03-19
04953170412035Single Use Rotatable Grasping Forceps FG-244NROLYMPUS MEDICAL SYSTEMS CORP.PTS2019-12-09
04953170412059Single Use Grasping Forceps FG-253SXOLYMPUS MEDICAL SYSTEMS CORP.PTS2019-12-09
04260206311096stentfix OTSC System SetOvesco Endoscopy AGOCZ2019-11-05
00350770927596Foreign Body Grasping ForcepsAvanos Medical, Inc.OCZ2019-09-10