FDA.report

Manta Ray

Primary DI
10889981136826
Brand
Manta Ray
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
22-99-0001-4
Catalog number
22-99-0001-4
Device description
Base
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OJHOrthopedic tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889981136826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088998113682610889981136826

GMDN Terms

TermDefinition
Instrument trayA flat shallow vessel, usually with a raised rim, providing a suitable platform for containing many medical, usually surgical instruments and items. It is typically made of stainless steel and designed to fit into other devices, e.g., supply trolleys, storage systems and sterilizers; it is not dedicated to sterilization. This device may or may not be fitted with a lid or cover. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

Regulatory Flags

DUNS number
079840876
Device count
1
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
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

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10889981125820Newport Complex MIS64-956564-95652026-03-03
10889981125851Newport Complex MIS64-959064-95902026-03-03
10889981130084Newport Complex MIS64-750564-75052026-03-03
10889981135331Newport Complex MIS64-552564-55252026-03-03
10889981135386Newport Complex MIS64-555564-55552026-03-03
10889981135393Newport Complex MIS64-556064-55602026-03-03
10889981135522Newport Complex MIS64-655064-65502026-03-03
10889981135553Newport Complex MIS64-656564-65652026-03-03
10889981135584Newport Complex MIS64-658564-65852026-03-03
10889981135591Newport Complex MIS64-659064-65902026-03-03
10889981135867Newport Complex MIS64-754564-75452026-03-03
10889981135997Newport Complex MIS64-851064-85102026-03-03
10889981136017Newport Complex MIS64-858564-85852026-03-03
10889981136079Newport Complex MIS64-957564-95752026-03-03
10889981136086Newport Complex MIS64-958564-95852026-03-03
10889981145668NewPort™65-474565-47452026-03-03
10889981145699NewPort™65-476065-47602026-03-03
10889981145750NewPort™65-555065-55502026-03-03
10889981145866NewPort™65-650065-65002026-03-03
10889981145903NewPort™65-653565-65352026-03-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00191072241979ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072241986ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072241993ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242006ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242013ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242020ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00869397000013XL Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000020Radiolucent Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000037Standard Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000044Removal System Instrument SetSi-Bone Inc.OJH2026-03-24
008693970000517.5mm & 10.75mm Instrument SetSi-Bone Inc.OJH2026-03-24
50198956278484CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956302929CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956307986CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956308006CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956357981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956360530CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956362015CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956366372CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956372472CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956377804CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956382600CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956387438CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956409819CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956415186CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956425697CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956426397CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956426762CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956427394CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956429312CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24