FDA.report

Regenx

Primary DI
00614950009503
Brand
Regenx
Company
ACE SURGICAL SUPPLY CO., INC.
Model
32905291
Catalog number
32905291
Device description
Symbios Socket Grafting KIT
Published
2018-03-06
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
KGNDRESSING, WOUND, COLLAGEN

Product Code Classifications

CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614950009503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950009503006149500095036149500095030614950009503

GMDN Terms

TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Device Sizes

TypeValueUnit
Length18Millimeter

Sterilization Methods

Method

Contacts

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
true
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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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

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Primary DIBrandCompanyProduct codePublished
00813954028873PuraKOTE+COLLAGEN MATRIX, INC.KGN2026-05-26
00813954028880PuraPLUG+COLLAGEN MATRIX, INC.KGN2026-05-26
00813954028897PuraTAPE+COLLAGEN MATRIX, INC.KGN2026-05-26
10885632434303HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-05-22
00812593023010Agilon Surgical Collagen+Biogennix, LLCKGN2026-03-24
00812593023027Agilon Surgical Collagen+Biogennix, LLCKGN2026-03-24
30888277720729MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
20888277720739MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
10813954028436Tissue Specialists Resorbable Collagen PlugCOLLAGEN MATRIX, INC.KGN2026-03-09
10813954028443Tissue Specialists Resorbable Collagen TapeCOLLAGEN MATRIX, INC.KGN2026-03-09
10813954028559bioPLUGCOLLAGEN MATRIX, INC.KGN2026-03-09
10381780545569PriMatrix®INTEGRA LIFESCIENCESKGN2026-03-04
00861092002637Cealogic RibbonRECIBIO, INC.KGN2026-03-01
00854780005515Architect FxHARBOR MEDTECH, INC.KGN2026-02-25
00813909013589Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013596Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013602Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013619Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013657Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013664Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013671Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013695Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
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05694310968065Kerecis MariGen®KERECIS hf.KGN2026-01-30
05694310968089Kerecis MariGen®KERECIS hf.KGN2026-01-30
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