FDA.reportPublic FDA data

Prosthetic Adhesives

Primary DI
05060483015736
Brand
Prosthetic Adhesives
Company
TECHNOVENT LIMITED
Model
ProBond Secure Adhesive, 30ml
Catalog number
G626
Device description
Solvent Based Silicone Pressure Sensitive (PSA) Adhesives to adhere craniofacial prostheses to skin.
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GBJProsthesis, Adhesive, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBJProsthesis, Adhesive, ExternalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060483015736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060483015736050604830157365060483015736

GMDN Terms#

Term, Definition table
TermDefinition
Skin surface device adhesiveA substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Special Storage Condition, Specify00Silicone Solvent Based PSA Adhesives are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers. Store out of direct sunlight.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
225835156
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060483010496MagnabutmentsB-MA1-S Mini Magnabutment (Branemark) – S-RangeB-MA1-S2024-10-14
05060483010502MagnabutmentsB-MA2-S Maxi Magnabutment (Branemark) – S-RangeB-MA2-S 2024-10-14
05060483010519MagnabutmentsE-MA1-S Mini Magnabutment (Cochlear Vistafix, histE-MA1-S2024-10-14
05060483010526MagnabutmentsE-MA2-S Maxi Magnabutment (Cochlear Vistafix, histE-MA2-S 2024-10-14
05060483010540MagnabutmentsS-MA2-S Maxi Magnabutment (Straumann ITI) – S-RangS-MA2-S2024-10-14
05060483010601MagnabutmentsP-MA1-5.0-S Mini Magnabutment (Medicon, 5.0mm) – SP-MA1-5.0-S2024-10-14
05060483010625MagnabutmentsP-MA2-1.6-S Maxi Magnabutment (Medicon, 1.6mm) – SP-MA2-1.6-S2024-10-14
05060483010632MagnabutmentsP-MA2-3.5-S Maxi Magnabutment (Medicon, 3.5mm) – SP-MA2-3.5-S2024-10-14
05060483010649MagnabutmentsP-MA2-5.0-S Maxi Magnabutment (Medicon, 5.0mm) – SP-MA2-5.0-S2024-10-14
05060483010656MagnabutmentsP-MA2-6.5-S Maxi Magnabutment (Medicon, 6.5mm) – SP-MA2-6.5-S2024-10-14
05060483010663MagnabutmentsIE-MA1-S Mini Magnabutment (Southern Implants) – SIE-MA1-S2024-10-14
05060483010670MagnabutmentsIE-MA2-S Maxi Magnabutment (Southern Implants) – SIE-MA2-S 2024-10-14
05060483010687MagnabutmentsIT-MA1-S Mini Magnabutment (Southern Implants) – SIT-MA1-S 2024-10-14
05060483010694MagnabutmentsIT-MA2-S Maxi Magnabutment (Southern Implants) – SIT-MA2-S2024-10-14
05060483010700MagnabutmentsHX-MA1-S Mini Magnabutment (Southern Implants) – SHX-MA1-S 2024-10-14
05060483010717MagnabutmentsHX-MA2-S Maxi Magnabutment (Southern Implants) – SHX-MA2-S2024-10-14
05060483010076Prosthetic AdhesivesProBond Adhesive 37mlG6092024-07-22
05060483010755‘MagnaCap’ Magnetic Retention SystemMini Magnacap Astra Uni Abutment S-Range AMC1-S 2024-07-22
05060483010762‘MagnaCap’ Magnetic Retention SystemMaxi Magnacap Astra Uni Abutment S-Range AMC2-S 2024-07-22
05060483010779‘MagnaCap’ Magnetic Retention SystemMini Magnacap - Lab AnalogueB-LAC1 2024-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060483010076Prosthetic AdhesivesTECHNOVENT LIMITEDGBJ2024-07-22
00810049490645Skinister MedicalDelta Molding LLCGBJ2024-05-14
00810049490652Skinister MedicalDelta Molding LLCGBJ2024-05-14
00810049490669Skinister MedicalDelta Molding LLCGBJ2024-05-14
07331791002984Provox Silicone GlueAtos Medical ABGBJ2022-07-12
DVIV562841AN1VirtualIVOCLAR VIVADENT AKTIENGESELLSCHAFTGBJ2017-03-29