FDA.reportPublic FDA data

Specials

Primary DI
10889981237875
Brand
Specials
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
SR-0384
Catalog number
SR-0384
Device description
Syringe Tip
Published
2020-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981237875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998123787510889981237875

GMDN Terms#

Term, Definition table
TermDefinition
Bone grafting cannulaA rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981137472Shoreline ACS86-001186-00112016-09-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G453CFK1000PEAK MEDICALPeak Medical Distribution Inc.GEA2026-03-23
G453AR130PEAK MEDICALPeak Medical Distribution Inc.GEA2026-03-11
00810130456109Medco ManufacturingMedco Manufacturing LLCGEA2026-02-27
00850080243145T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
00850080243152T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
00850080243169T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
20860002896964TalarusCannuflow, Inc.GEA2026-01-28
04058749082937NAFehling Instruments GmbH & Co. KGGEA2026-01-28
00840329836795N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-16
00840329837013N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-16
07630542741012CannulaMedacta International SAGEA2026-01-16
07630542741029CannulaMedacta International SAGEA2026-01-16
07630542741036CannulaMedacta International SAGEA2026-01-16
07630542746499CannulaMedacta International SAGEA2026-01-16
07630542746505CannulaMedacta International SAGEA2026-01-16
07630542746512CannulaMedacta International SAGEA2026-01-16
00840329836375N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836382N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836399N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836405N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836412N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836429N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836443N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836450N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836467N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836474N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836481N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836498N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836504N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836542N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15