FDA.reportPublic FDA data

Disc Prep

Primary DI
10889981104016
Brand
Disc Prep
Company
Seaspine Orthopedics Corporation
Model
06-50-0040
Catalog number
06-50-0040
Device description
Forceps-Bipolar Angled
Published
2016-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981104016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998110401610889981104016

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981080877Malibu91-214791-21472016-05-02
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
08806373899997BENCOXCorentec Co., LtdHTD2026-06-09
04052536162000neon3Ulrich GmbH & Co. KGHTD2026-06-08
04052536162017neon3Ulrich GmbH & Co. KGHTD2026-06-08
00810189451001Surgical DesignSurgical Design, Inc.HTD2026-06-06
G8142900SF3Garish ApparelsGARISH APPARELSHTD2026-06-06
G8142900SFFPPP3Garish ApparelsGARISH APPARELSHTD2026-06-06
G8142905SF3Garish ApparelsGARISH APPARELSHTD2026-06-06
04046964683039AESCULAPAESCULAP, INC.HTD2026-06-05
00766588283463Cohesive Wrap - 2"x 5 ydsCertified Safety Manufacturing, Inc.HTD2026-06-04
10766588283460Cohesive Wrap - 2"x 5 yds - UDI/10Certified Safety Manufacturing, Inc.HTD2026-06-04
04052536161959neon3Ulrich GmbH & Co. KGHTD2026-05-28
04052536161966neon3Ulrich GmbH & Co. KGHTD2026-05-28
04052536161973neon3Ulrich GmbH & Co. KGHTD2026-05-28
D9282000201SUL0SMITH SAGGITAL SPLITTER-MODW.H. Holden, Inc.HTD2026-05-27
G4250601180My MedicalMy Medical Store LLCHTD2026-05-04
G4250601350My MedicalMy Medical Store LLCHTD2026-05-04
G4250602970My MedicalMy Medical Store LLCHTD2026-05-04
G4250602980My MedicalMy Medical Store LLCHTD2026-05-04
G425310840NC0My MedicalMy Medical Store LLCHTD2026-05-04
G4254402140My MedicalMy Medical Store LLCHTD2026-05-04
G4254403120My MedicalMy Medical Store LLCHTD2026-05-04
G8142900SFPP3Garish ApparelsGARISH APPARELSHTD2026-04-28
09348811015402INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-21
09348811012678INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012722INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012913INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811013163INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811014603INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811129345INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
04052536052912uCentumUlrich GmbH & Co. KGHTD2025-08-04