FDA.report

ACE

Primary DI
00614950000159
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
0034227
Catalog number
0034227
Device description
SOCKET PRESERVATION KIT
Published
2017-11-22
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
NPMBONE GRAFTING MATERIAL, ANIMAL SOURCE

Product Code Classifications

CodeDeviceSpecialtyClass
NPMBone Grafting Material, Animal SourceDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614950000159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950000159006149500001596149500001590614950000159

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
Width1Centimeter

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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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

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