FDA.reportPublic FDA data

ACE Medical

Primary DI
00840217904605
Brand
ACE Medical
Company
Ebner Medical
Model
TOBLER1
Catalog number
TOBLER1
Device description
Cloward Spreader, spinloc, 130mm tip extended by 18mm
Published
2021-06-08
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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840217904605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217904605008402179046058402179046050840217904605

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length130Millimeter
Width18Millimeter

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
true
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
00840217908603Ace Medical CompanyACEBAY07-20TCACEBAY07-20TC2024-01-16
00840217908610Ace Medical CompanyACEDET08-30SACEDET08-30S2024-01-16
00840217908504Wiggins Medical52-731-01B52-731-01B2024-01-05
00840217908511Wiggins Medical52-731-02EB52-731-02EB2024-01-05
00840217908528Wiggins Medical52-731-03EB52-731-03EB2024-01-05
00840217908535Wiggins Medical52-731-04EB52-731-04EB2024-01-05
00840217908542Wiggins Medical52-731-05EB52-731-05EB2024-01-05
00840217908481Ace Medical AA9772020AA97720202023-12-26
00840217908498Ace Medical AA9772030AA97720302023-12-26
00840217907941ACE MedicalAA9781230AA97812302023-12-16
00840217908009Ace Medical CoAA9824023AA98240232023-07-13
00840217908474Wiggins Medical52-741-01B2023-11-09
00840217908443Wiggins Medical52-742-02SPFB2023-11-03
00840217908436Ace Medical CompanyECA-C0012023-10-25
00840217908399Ace Medical CompanyCNA-15L202023-10-23
00840217908405Ace Medical CompanyCMI-20L252023-10-23
00840217908412Ace Medical CompanyECA-C0282023-10-23
00840217908429Ace Medical CompanyECA-C0292023-10-23
00840217908382Ace Medical CoEE7033530V2023-09-29
00840217908368Ace Medical CompanyAA66620902023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800171Adler Instrument CompanyAdler, Inc.MDM2026-05-26
00810220800188Adler Instrument CompanyAdler, Inc.MDM2026-05-26
06438394002678Activa InstrumentBioretec OyMDM2026-03-23
06438394002685Activa InstrumentBioretec OyMDM2026-03-23
06438394002692Activa InstrumentBioretec OyMDM2026-03-23
06438394020382Activa InstrumentBioretec OyMDM2026-03-23
06438394010956Activa InstrumentBioretec OyMDM2026-03-23
00198506089619ELMED INCORPORATEDELMED INCORPORATEDMDM2026-03-17
00888867519459Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519473Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519503Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519510Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529755Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529793Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529823Arthrex®ARTHREX, INC.MDM2026-03-16
00198506089510ELMED INCORPORATEDELMED INCORPORATEDMDM2026-03-13
00810158219236PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219243PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219250PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219281PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219304PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219311PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219359PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219373PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219007PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219014PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219021PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219038PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219069PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219090PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11