FDA.reportPublic FDA data

SILK

Primary DI
10790986006833
Brand
SILK
Company
C.P. MEDICAL CORPORATION
Model
640SRT
Catalog number
640SRT
Device description
*FOR EVALUATION PURPOSES ONLY*
Published
2016-11-17
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

Product Codes#

Code, Name table
CodeName
GAPSuture, Nonabsorbable, Silk

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10790986006833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1079098600683310790986006833

GMDN Terms#

Term, Definition table
TermDefinition
Silk sutureA natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
807404611
Device count
1
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00790986000001CP Cotton Umbilical TapeCP10A2024-03-29
00790986000551CP Cotton Umbilical TapeCP11A2015-09-24
00790986000568CP Cotton Umbilical TapeCP12A2015-09-24
20790986000555CP Cotton Umbilical TapeCP11A2015-09-24
20790986006298FN NEEDLESFN18-51TFN18-51T2016-02-19
20790986006304FN NEEDLESFN18-3TFN18-3T2016-02-19
20790986006311FN NEEDLESFN18-1TFN18-1T2016-02-19
20790986006328FN NEEDLESFN17-51TFN17-51T2016-02-19
20790986006335FN NEEDLESFN17-3TFN17-3T2016-02-19
20790986006342FN NEEDLESFN17-1TFN17-1T2016-02-19
20790986006878FN NEEDLESFN18-53T2017-11-06
10790986001005MONO-DOXM1842016-07-26
20790986001019MONO-DOXM3042016-07-26
20790986001026MONO-DOXM305M3052016-06-13
20790986001033MONO-DOXM310M3102016-06-13
20790986001040MONO-DOXM311M3112016-06-13
20790986001057MONO-DOXM3152016-07-26
20790986001071MONO-DOXM317M3172016-07-26
20790986001088MONO-DOXM332M3322016-06-13
20790986001095MONO-DOXM333M3332016-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837747518SILKHEALTHIUM MEDTECH LIMITEDGAP2026-05-25
10841336117645Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117898Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
00841336117907Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117911Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117928Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117935Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117942Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117959Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
00840277410153SilkRIVERPOINT MEDICAL, LLCGAP2025-07-29
10814639026747Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026754Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026761Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026778Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026785Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026792Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10840277408577SilkRIVERPOINT MEDICAL, LLCGAP2025-06-18
10840277408591RiversilkRIVERPOINT MEDICAL, LLCGAP2025-06-18
10848782052025OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052032OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052049OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052056OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052063OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052070OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052278OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10840277409192SilkRIVERPOINT MEDICAL, LLCGAP2025-03-13
10840277409208SilkRIVERPOINT MEDICAL, LLCGAP2025-03-13
10840277408560SilkRIVERPOINT MEDICAL, LLCGAP2025-02-28
10840277408584RiversilkRIVERPOINT MEDICAL, LLCGAP2025-02-28
10840277408843SilkRIVERPOINT MEDICAL, LLCGAP2025-02-28