FDA.reportPublic FDA data

ACE Medical

Primary DI
00840217905206
Brand
ACE Medical
Company
EBNER MEDICAL, LLC
Model
ACE07-10S EX
Catalog number
ACE07-10S EX
Device description
7" PVD Coated Black Kerrison 1mm Standard Footplate
Published
2021-06-08
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
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200387000Ace Medical Surgical InstrumentsAce Medical2020-07-21HAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840217905206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217905206008402179052068402179052060840217905206

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Width0

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
false
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
00840217910002Ace Medical CompanySW001-Box12025-10-07
00840217908351Wiggins MedicalWM-SCTRAY001WM-SCTRAY-0012023-08-23
00840217907057ACE MedicalAA9791823AA97918232022-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776439880MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776439897MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776440879MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776439835MilleniumAvalign Technologies, Inc.HAE2026-10-28
B382SD9228132210Surgical DirectSurgical Direct, Inc.HAE2026-10-20
B382SD9228132220Surgical DirectSurgical Direct, Inc.HAE2026-10-20
00840217900089Wiggins MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900096Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900171Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900188Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900195Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900201Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900218Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900225Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900232Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900249Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900256Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900263Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900270Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900287Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900294Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900300Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900317Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900324Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900331Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900348Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900355Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900362Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900379Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900386Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29