FDA.reportPublic FDA data

Endo ECTR Tray

Primary DI
00857915007750
Brand
Endo ECTR Tray
Company
A.M. SURGICAL, INC.
Model
9600
Published
2026-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857915007750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857915007750008579150077508579150077500857915007750

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
160020087
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857915007767IM Nail Awl8900-202026-06-10
00857915007774Measuring Device8900-512026-06-10
00857915007804STRATOS Endoscopic Release System (GEN 2) Case of 55500-B2026-06-10
00857915007811Table Pad95012026-06-10
10857915007818Table Pads (5-pack)9501-B2026-06-10
20857915007815STRATOS Endo Release Kit (GEN 2) Case of 55500-K2026-06-10
00857915007705STRATOS (Gen2)5500-22026-06-05
00857915007033RetraBE Single - Gen 2 Depricated5500-SRB2026-06-04
00857915007743Hand Table95002026-06-04
00857915007781Retra Uni Gen 1 (5-Pack)5500-UB2026-06-04
00857915007798Retra Uni Gen 1 Single5500-U2026-06-04
10857915007030RETRA Single - GEN 2 Depricated5500-RB2026-06-04
00857915007026Scope Adapter1200-012026-06-01
00857915007712Obturator9600-012026-06-01
00857915007729Cannula9600-022026-06-01
00857915007736Rasp9600-032026-06-01
00857915007699Locking Attachment9600-042026-05-20
00857915007132Stratos55002019-07-17
10857915007047RETRA5500-RN/A2026-05-20
00857915007040RETRA5500-SR2026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376766133InvictusALPHATEC SPINE, INC.FSM2026-07-30
ESAM1380200003041STOMA®Storz am Mark GmbHFSM2026-07-30
ESAM1380210003041STOMA®Storz am Mark GmbHFSM2026-07-30
ESAM1387030003041STOMA®Storz am Mark GmbHFSM2026-07-30
03700569678968Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-28
10889950157623Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-07-28
00190376768748Segmental Plating SystemALPHATEC SPINE, INC.FSM2026-07-27
00810017915118Saber-C Instrument CaseELEVATION SPINE, INC.FSM2026-07-27
03700569674304Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674311Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674373Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674380Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674397Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674403Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674410Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674427Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674441Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674458Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674465Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680145Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680152Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680169Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680176Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
00190776422011MillenniumAvalign Technologies, Inc.FSM2026-07-24
00840536823717VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
00840536823724VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
07640221370846SCALASpineArt SAFSM2026-07-24
07640221370853SCALASpineArt SAFSM2026-07-24
07640221370860SCALASpineArt SAFSM2026-07-24
00190776421991MillenniumAvalign Technologies, Inc.FSM2026-07-23