FDA.reportPublic FDA data

Ace Medical Company

Primary DI
00840217909389
Brand
Ace Medical Company
Company
EBNER MEDICAL, LLC
Model
90-100-04
Catalog number
90-100-04
Device description
Penfield Dissector, 20.5 cm spatula slightly curved
Published
2024-12-09
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
false

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
00840217909389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217909389008402179093898402179093890840217909389

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-822-0314info@acemedicalco.com

Regulatory Flags#

DUNS number
106135367
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00840217910170Ace Medical CompanyAA4021010AA40210102026-08-13
00840217910187Ace Medical CompanyAA4021015AA40210152026-08-13
00840217910194Ace Medical CompanyAA4021023AA40210232026-08-13
00840217910200Ace Medical CompanyAA4021223AA40212232026-08-13
00840217910217Ace Medical CompanyAA4021215AA40212152026-08-13
00840217910224Ace Medical CompanyAA4021410AA40214102026-08-13
00840217910231Ace Medical CompanyAA4021415AA40214152026-08-13
00840217910248Ace Medical CompanyAA40214232026-08-13
00840217910255Ace Medical CompanyAA4021605AA40216052026-08-13
00840217910262Ace Medical CompanyAA4021608AA40216082026-08-13
00840217910279Ace Medical CompanyECA-A008ECA-A0082026-08-13
00840217910286Wiggins Medical90-070-25FB90-070-25FB2026-08-13
00840217910293Ace Medical CompanyER806.000PAER806.000PA2026-08-13
00840217910309Ace Medical CompanyER806.000VAER806.000VA2026-08-13
00840217910316Ace Medical CompanyER300.010ERER300.010ER2026-08-13
00840217910323Ace Medical CompanyER305.200ER1ER305.200ER12026-08-13
00840217910330Ace Medical CompanyER305.150EER305.150E2026-08-13
00840217910347Ace Medical CompanyER300.020BAER300.020BA2026-08-13
00840217910354Ace Medical CompanyER390.070ER390.0702026-08-13
00840217910361Wiggins Medical90-070-18FB2026-08-13

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
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
10840199533326DissectorKOROS U.S.A., INC.GDI2024-02-06