FDA.reportPublic FDA data

ACE

Primary DI
00614950028054
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
7351520
Catalog number
7351520
Device description
MemGuide Dental Membrane
Published
2023-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00614950028054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950028054006149500280546149500280540614950028054

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone void filling material, animal-derivedA bioabsorbable, implantable device made primarily of animal-derived materials (e.g., bovine, porcine) intended to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill bone cavities and defects. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Contacts#

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

Regulatory Flags#

DUNS number
042763706
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950007547OUSIA bioXENOUSM2OUSM22015-10-24
00614950007554OUSIA bioXENOUSM3OUSM32015-10-24
00614950007561OUSIA bioXENOUSM4OUSM42015-10-24
00614950007578OUSIA bioXENOUSM5OUSM52015-10-24
00614950007585OUSIA bioXENOUSM6OUSM62015-10-24
00614950007721OUSIA bioXENOUSM1OUSM12015-10-24
00614950027910Collagen Matrix509400150940012023-06-16
00614950027927Collagen Matrix509400250940022023-06-16
00614950027934MinerOss® XBH0034BH00342022-10-27
00614950027941MinerOss® XBH0035BH00352022-10-27
00614950027958MinerOss® XBH0036BH00362022-10-27
00614950027965MinerOss® XBH0037BH00372022-10-27
00614950027972MinerOss® XBH0038BH00382022-10-27
00614950027989MinerOss® XBH0039BH00392022-10-27
00614950027996MinerOss® XBH0044BH00442022-10-27
00614950028009MinerOss® XBH0045BH00452022-10-27
00614950028016MinerOss® XBH0046BH00462022-10-27
00614950028023MinerOss® XBH0047BH00472022-10-27
00614950028030MinerOss® XBH0052BH00522022-10-27
00614950028047MinerOss® XBH0053BH00532022-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810179632328DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632359DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632366DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632373DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632878DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632885DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632892DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632908DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632915DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632922DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
07610221017645Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
07610221017652Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
07610221017669Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
09421907331614Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
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
06974944921339NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
06974944921346NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
06974944921353NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16