FDA.reportPublic FDA data

SILICONE PUTTY

Primary DI
00841494104641
Brand
SILICONE PUTTY
Company
Ellman International
Model
ECM180
Catalog number
ECM180
Device description
SILICONE PUTTY COMPRESSION MAT, 3OZ. JAR
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EBLPIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBLPin, Retentive And Splinting, And Accessory InstrumentsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494104641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494104641008414941046418414941046410841494104641

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079095245
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841494102371CORNEAL SHIELDH77AH77A2016-09-21
00841494102388CORNEAL SHIELDH76AH76A2016-09-21
00841494102395CORNEAL SHIELDH75AH75A2016-09-21
00841494102401CORNEAL SHIELDSH781H7812016-09-21
00841494104801SUCTION HANDLEH78BH78B2016-09-21
00841494104818SUCTION HANDLE FOR CORNEAL SHIELDSH78AH78A2016-09-21
008414941010151/8" PIN ELECTRODE133D133D2016-09-19
00841494101305Needle ElectrodeA3D/OSA3D/OS2016-09-21
00841494101541Empire Microincision Needle ElectrodesQTEE302QTEE3022016-09-21
10841494101807RF ANGLED SUCTION COAGULATORHD42HD422016-09-21
00841494102012BALL ELECTRODED8DD8D2016-09-21
00841494102050DR. Beigi's ElectrodesTEE603TEE6032016-09-21
00841494102289BROAD NEEDLE ELECTRODEF1DF1D2016-09-21
00841494102524Dermatology ElectrodesDDERM40DDERM402016-09-21
00841494102531DIAMOND LOOP ELECTRODEC3DC3D2016-09-21
00841494102777EMPIRE microIncision Needle ElectrodesTEE316TEE3162016-09-21
00841494102784EMPIRE microIncision Needle ElectrodesTEE302TEE3022016-09-21
00841494102791EMPIRE microIncision Needle ElectrodesTEE314TEE3142016-09-21
00841494102807EMPIRE microIncision Needle ElectrodesTEE317TEE3172016-09-21
00841494102814EMPIRE microIncision Needle ElectrodesTEE326TEE3262016-09-21

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