FDA.report

BIOGRAN®

Primary DI
00844868036104
Brand
BIOGRAN®
Company
BIOMET 3I, LLC
Model
2100-0004
Device description
707020-F-BIOGRAN® 750MG (CUP) CONTENTS: 7 STERILE 750MG CUPS
Published
2015-08-31
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

Related Records

Contact Domains

Product Codes

CodeName
LYCBone grafting material, synthetic

Product Code Classifications

CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844868036104PrimaryGS10
30844868036105Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844868036104008448680361048448680361040844868036104
3084486803610530844868036105

GMDN Terms

TermDefinition
Bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes

TypeValueUnit
Weight750Milligram

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)342-54543iPBG-CS@biomet.com

Regulatory Flags

DUNS number
186127825
Device count
7
DM exempt
false
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

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10813954028566bioKOTECOLLAGEN MATRIX, INC.LYC2026-03-09
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072900148381853D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381923D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148382083D BondAUGMA BIOMATERIALS LTDLYC2026-02-04
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07290014838130Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-01-15
00813954028392SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
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00813909013336Dental Putty Syringe 1.0ccNOVABONE PRODUCTS, LLCLYC2025-04-25
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