FDA.reportPublic FDA data

General Instruments

Primary DI
00811801037276
Brand
General Instruments
Company
ALPHATEC SPINE, INC.
Model
CI-10409
Device description
Penfield 4 w/Larger Handle
Published
2020-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811801037276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811801037276008118010372768118010372760811801037276

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags#

DUNS number
602465783
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
00840967110981AlphaGRAFT1002-1002015-09-24
00840967110998AlphaGRAFT1001-0102015-09-24
00840967111001AlphaGRAFT1001-1002015-09-24
00844856026711AlphaGRAFT1001-0502015-09-24
00844856026728AlphaGRAFT1002-0252015-09-24
00844856026735AlphaGRAFT1002-0502015-09-24
00844856032231Osseofix +213902016-10-28
00190376649474CONTOUR3DAIX761032026-09-25
00190376652313CONTOUR3DAIX761012026-09-25
00190376652320CONTOUR3DAIX761022026-09-25
00190376652337CONTOUR3DAIX761042026-09-25
00190376668307CONTOUR3DAIX760002026-09-25
00190376733470CONTOUR3DC3DRODA2026-09-25
00190376778372InvictusVMRIN2026-08-19
00190376778396InvictusVMTIN2026-08-19
00190376768847Invictus171442026-08-17
00190376544397Invictus17920-012026-07-30
00190376544403Invictus17920-022026-07-30
00190376544410Invictus17920-032026-07-30
00190376544427Invictus17920-042026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433765MillenniumAvalign Technologies, Inc.GDI2026-10-08
00190776433758MillenniumAvalign Technologies, Inc.GDI2026-10-07
G141530254210Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14155805410Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14155805420Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14167216050Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G1415530254210Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-09-30
00190776432461MillenniumAvalign Technologies, Inc.GDI2026-09-24
G4533310930PEAK MEDICALPeak Medical Distribution Inc.GDI2026-08-27
00190776419110MillenniumAvalign Technologies, Inc.GDI2026-08-23
00840217910286Wiggins MedicalEBNER MEDICAL, LLCGDI2026-08-13
00190776424367MillenniumAvalign Technologies, Inc.GDI2026-08-07
00190776408626MillenniumAvalign Technologies, Inc.GDI2026-08-03
B382SD914709040Surgical DirectSurgical Direct, Inc.GDI2026-07-29
00810068850765Biocore9 Acetabular Bearing SystemBiocore9, LLCGDI2026-06-26
07898789390121ENDOFOREHEAD DISSECTOR 5MM ANGLEDTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-06-09
07898789390138ENDOFOREHEAD DISSECTOR WITH SUCTION STRAIGHT 30CMTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-06-09
07898789390039GRAIVIER MID-FACE DISSECTOR LEFTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390046GRAIVIER MID-FACE DISSECTOR RIGHTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390060FRONTO MARTINS 2 ENDOFOREHEAD DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
00196449034512Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
00840217909570Wiggins MedicalEBNER MEDICAL, LLCGDI2025-04-08
00840217909587Wiggins MedicalEBNER MEDICAL, LLCGDI2025-04-08
00840217909358Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909365Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909372Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909389Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
10840199523402DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533302DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533319 DissectorKOROS U.S.A., INC.GDI2024-02-06