FDA.report

OUSIA bioXEN

Primary DI
00614950028443
Brand
OUSIA bioXEN
Company
ACE SURGICAL SUPPLY CO., INC.
Model
OUSM1SEU
Catalog number
OUSM1SEU
Device description
bioXEN Cancellous 0.6cc 0.25-1mm Particulate
Published
2023-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NPMBONE GRAFTING MATERIAL, ANIMAL SOURCE

Product Code Classifications

CodeDeviceSpecialtyClass
NPMBone Grafting Material, Animal SourceDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614950028443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950028443006149500284436149500284430614950028443

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume0.6Milliliter

Sterilization Methods

Method

Contacts

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

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00614950029655Macan003333700333372023-12-05
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00614950029693Macan526002952600292023-12-05

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