OUSIA bioMAINTAIN

Primary DI
00614950007684
Brand
OUSIA bioMAINTAIN
Company
ACE SURGICAL SUPPLY CO., INC.
Model
OUSA2S
Catalog number
OUSA2S
Device description
OUSIA bioMAINTAIN 20X30MM RESORBABLE DENTAL MEMBRANE
Published
2015-10-24
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
00614950007684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950007684006149500076846149500076840614950007684

GMDN Terms#

Term, Definition table
TermDefinition
Collagen dental regeneration membraneA sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100ritaknight@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
true
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
00614950031863BioPlugBH0054BH00542024-05-22
00614950031870BioStripBH00055BH000552024-05-22
00614950029525ACE400000140000012023-12-05
00614950029532ACE401500240150022023-12-05
00614950029549ACE400200740020072023-12-05
00614950029556ACE603901560390152023-12-05
00614950029563ACE603901660390162023-12-05
00614950029570ACE442305044230502023-12-05
00614950029587ACE090010209001022023-12-05
00614950029594Macan003333900333392023-12-05
00614950029600Macan526003552600352023-12-05
00614950029617Macan526003852600382023-12-05
00614950029624Macan526600052660002023-12-05
00614950029631Macan003334200333422023-12-05
00614950029648Macan526004552600452023-12-05
00614950029655Macan003333700333372023-12-05
00614950029662Macan526002652600262023-12-05
00614950029679ACE400520340052032023-12-05
00614950029686Macan003337600333762023-12-05
00614950029693Macan526002952600292023-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028590bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-03-23
00813954028606bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-03-23
00813954028613bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-03-23
00813954028453Tissue Specialists Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-03-09
00813954028460Tissue Specialists Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-03-09
00813954028477Tissue Specialists Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-03-09
00813954027470RCM6COLLAGEN MATRIX, INC.NPL2026-01-07
00813954027487RCM6COLLAGEN MATRIX, INC.NPL2026-01-07
00813954027494RCM6COLLAGEN MATRIX, INC.NPL2026-01-07
00813954027852conFORMCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954027869conFORMCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954027876conFORMCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028019bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028026bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028033bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028040bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028057bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028064bioADAPTCOLLAGEN MATRIX, INC.NPL2026-01-07
00813954028071Bicon Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028088Bicon Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028095Bicon Resorbable Collagen MembraneCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028323bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028330bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028347bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028354bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028361bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00813954028378bioMAINTAINCOLLAGEN MATRIX, INC.NPL2026-01-06
00841336110984Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPL2025-09-28
00841336111028Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPL2025-09-28
00841336111080Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPL2025-09-28