FDA.reportPublic FDA data

ACE

Primary DI
00614950028078
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
7353040
Catalog number
7353040
Device description
MemGuide Dental Membrane
Published
2023-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPLBarrier, animal source, intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPLBarrier, Animal Source, IntraoralDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950028078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950028078006149500280786149500280780614950028078

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, animal-derivedA sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100regulatoryandquality@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950025510ACE003293700329372019-10-24
00614950025558ACE080000208000022019-10-24
00614950025565ACE080000308000032019-10-24
00614950025572ACE080001108000112019-10-24
00614950013425ACE003105900310592019-10-16
00614950031207ACE484200248420022023-12-05
00614950031214ACE484200348420032023-12-05
00614950030149ACE20982511209825112023-12-05
00614950030927ACE45450201454502012023-12-05
00614950012831ACE90440018S90440018S2019-10-13
00614950012848ACE90440018ST90440018ST2019-10-13
00614950026272ACE90250018902500182019-10-13
00614950026289ACE90250023902500232019-10-13
00614950026296ACE90440018904400182019-10-13
00614950026302ACE90440023904400232019-10-13
00614950026319ACE90440023S90440023S2019-10-13
00614950026326ACE90440023ST90440023ST2019-10-13
00614950026333ACE90500018905000182019-10-13
00614950026340ACE90500018S90500018S2019-10-13
00614950026357ACE90500023905000232019-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09421907331621Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331638Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331652Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331706Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331713Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331720Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331744Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331799Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331805Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331812Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331836Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
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06974944921742NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
06974944921759NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16